MAUDE Adverse Event Report: MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM; DACAPO POWERPACK (TEMPO ACCU WYON)

Lot Number 1405O002

Device Problems Break (1069); Leak/Splash (1354)

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

Event Type  malfunction  

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

The returned device was visually inspected upon arrival.A mechanically damaged housing was observed, most likely due to external mechanical stress.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.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Type of Device: DACAPO POWERPACK (TEMPO ACCU WYON)
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH; innsbruck ; AU
• Manufacturer Contact: laura simonotti ; fuerstenweg 77a; innsbruck A-602-0 ; AU A-6020 ; 6460705562
• MDR Report Key: 4817964
• MDR Text Key: 5894915
• Report Number: 9710014-2015-00374
• 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
• Type of Report: Initial
• Report Date: 05/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 1405O002
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/05/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/12/2015
• 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
• Patient Age: 13 YR