| Class 2 Device Recall HiRes90K Platinum Series Headpiece |  |
Date Initiated by Firm | July 24, 2008 |
Date Posted | February 03, 2009 |
Recall Status1 |
Terminated 3 on March 23, 2012 |
Recall Number | Z-0956-2009 |
Recall Event ID |
50204 |
PMA Number | P960058 |
Product Classification |
cochlear implant - Product Code MCM
|
Product | HR90K Platinum Series Headpiece Model Number AB-7300-001 ADVANCED BIONICS LLC 12740 San Fernando Rd. Sylmar, CA 91342 USA. The HiRes90K headpiece is used in conjunction with speech processors manufactured by Advanced Bionics.
The Harmony HiResolution Bionic Ear System and Clarion Multi-Strategy Cochlear Implant are cochlear implant systems designed to provide useful hearing to individuals with severe-to-profound sensorineural hearing loss. |
Code Information |
Model #AB-7300-001; Serial Numbers: 167419, 167420, 169309, 169310, 169311, 170983, 170984, 170985, 172709, 172710, 174272, 174274, 174275, 174298, 175139, 175988, 175989, 175990, 175991, 177627, 177628, 177629, 177630, 177631, 177671, 177672, 177673, 178494, 179252, 181303, 181304, 183489, 184405 and 184694 |
Recalling Firm/ Manufacturer |
Advanced Bionics LLC 12740 San Fernando Rd Sylmar CA 91342-3728
|
For Additional Information Contact | 877-244-9541 |
Manufacturer Reason for Recall | Mistuned headpiece - Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Series
headpieces shipped from May 2007 through April 2008. Tuning refers to the process through which the headpiece's communication
frequency is adjusted to match that of the internal device. Potential clinical
symptoms include:
-No lock
-Intermittent lock
-Implant locks, but cann |
FDA Determined Cause 2 | Employee error |
Action | Advanced Bionics is notifying clinicians of this situation so that they can provide
appropriate clinical management. The notification letter sent to clinicians in the
United States was sent via FedEx so that delivery information could be confirmed. The letter advises that Advanced Bionics recently became aware of a tuning issue with some Platinum Series and S-Series headpieces shipped from May 2007 through April 2008. Auria and Harmony headpieces are not
affected by this issue. Tuning refers to the process through which the headpiece's communication frequency is adjusted to match that of the internal device.
Since discovery of this issue firm has conducted an extensive technical analysis showing that the use of these headpieces does not pose any safety risk to the patient. While there has been no increase in the
number of headpiece-related complaints, firm advises of the potential clinical
symptoms:
-No lock
-Intermittent lock
-Implant locks, but cannot measure impedances
-Reduction in battery life, primarily for C1 patients with thick flaps.
Per the letter, as long as the system maintains lock, there is no degradation in sound quality or
stimulation. Further, the impact on battery life for CII and HiRes 90K patients is minimal.
Medical professionals are advised that If they have any patients who display any of these clinical symptoms that they attribute to an affected
headpiece, to advise the patient to contact Advanced Bionics Customer Service at 877-244-9541 and they will send them a replacement promptly. |
Quantity in Commerce | 2,049 units |
Distribution | Nationwide |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
PMA Database | PMAs with Product Code = MCM
|
|
|
|