La lettera dice che ci sono stati due persone che 8-10 giorni post-attivazione hanno sentito rumori forti e shock. Ci sono altri 9 casi sospetti ma non confermati. Il motivo per questa informazione non è per creare allarmismo ma per rendere accessibili tutte le informazioni perchè mentre un adulto può spiegare ciò che sente, un bambino non può comunicare e come genitori possiamo pensare che è solo un discorso di dover abituarsi al nuovo modo di sentire. C'è scritto che dovete monitorare questa cosa per un periodo di 90 giorni post-attivazione e che l'AB continuerà ad informarci riguardo allo stato dell'indagine. Se il bambino manifesta qualsiasi segnale ambiguo, levate subito il processore esterno e chiama la clinica dove è stato operato.
Advanced Bionics website - November 23, 2010
---------------**** Recall Notification****
Advanced Bionics HiRes 90K Cochlear Implant
Dear Cochlear Implant Recipient or Parent,
Our mission at Advanced Bionics is to improve the lives of the hearing
impaired, and the safety and well-being of our recipients is our first priority. Because we are committed to ensuring that our products are as safe as possible, we are voluntarily informing you that we have become aware of an issue with the HiRes 90K cochlear implant.
The issue can result in pain, overly loud sounds, and/or sudden shock sensation in the implanted ear while the implant is receiving power. Thus far, our investigation shows that of the more than 28,000 implanted HiRes 90K devices, only two explanted devices have been confirmed to have this issue. There are 9 other patients with similar symptoms which our investigations have not yet ruled out as related to this issue. For the two confirmed cases, there were no symptoms upon initial activation of device.
However, the patients experienced symptoms after 8-10 days of use. Both recipients were re-implanted with HiRes 90K devices and their clinicians report that they are progressing well.
We are conducting an extensive investigation of this issue using an
independent scientific research organization. Their current analysis suggests that, if present, the issue will first occur within 90 days of device use. However, the onset of symptoms may be delayed after initial activation, and they may continue to occur intermittently.
In the unlikely event that this symptom occurs, continued device use may lead to
damage to the inner ear and/or the auditory nerve. If you or your child experience
pain related to implant use, remove the external equipment immediately and contact your cochlear implant clinician to schedule an appointment. If the evaluation of your device identifies this problem, device replacement is advised.
It is important to note that it is not unusual for cochlear implant recipients to experience overly loud sounds. Most of these cases can be resolved with standard
troubleshooting, such as the replacement of external equipment. The vast majority of these cases are not signs of the issue described above and do not require explant of the device.
We will notify you again as more information from our investigation becomes
available.
We sincerely regret any concern this notification may cause. Advanced
Bionics assures you that we will correct this issue and continue to improve our product reliability.
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