MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM; EXTERNAL COMPONENT

Model Number DACAPO POWERPACK (TEMPO ACCU WYON)

Device Problems Break (1069); Leak/Splash (1354); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Conclusion: the returned device was visually inspected upon arrival.A mechanically damaged housing was observed.The observed damage did not allow electrical testing to be conducted.The damage to the battery housing was clearly the reason for the malfunction of the device returned by the end-user.This is a combined initial and final report.

Event Description

Returned dacapo power pack showed a broken housing with electrolyte leakage.However, neither patient contact to battery chemistry nor any injuries were reported.

Manufacturer Narrative

Conclusion: the returned device was visually inspected upon arrival.A mechanically damaged housing was observed.The observed damage did not allow electrical testing to be conducted.The damage to the battery housing was clearly the reason for the malfunction of the device returned by the end-user.This report is a correction for the procode (mpv instead of mcm was selected in the previous report).

Event Description

Returned dacapo power pack showed a broken housing with electrolyte leakage.However, neither patient contact to battery chemistry nor any injuries were reported.

• Brand Name: MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
• Type of Device: EXTERNAL COMPONENT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck 6020 ; AU 6020 ; 57788
• MDR Report Key: 5041571
• MDR Text Key: 25307903
• Report Number: 9710014-2015-00617
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DACAPO POWERPACK (TEMPO ACCU WYON)
• Device Lot Number: 0811B004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1