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

Model Number ZINC AIR BATTERIES

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/02/2020

Event Type  malfunction  

Manufacturer Narrative

The batteries have not been returned to med-el hq.When available, a failure analysis will be submitted as a follow up report.

Event Description

Reportedly there have been a few occurrences of 1 or sometimes 2 of the installed disposable power one implant plus p675 batteries swelling since the end of 2019.On (b)(6) 2020, 1 of the disposable batteries expanded inside of the battery cover and cracked it.The user was not wearing the device at the time and there was no injuries associated with this event.The unit was reported to be sitting on the kitchen counter in comfortable room temperature when the unit heated up.

Event Description

Reportedly there have been a few occurrences of 1 or sometimes 2 of the installed disposable power one implant plus 675 batteries swelling since the end of 2019.On (b)(6) 2020, one of the disposable batteries exploded inside of the battery frame/cover and cracked it.The user was not wearing the device at that time and there was no injury associated with this event.

Manufacturer Narrative

Conclusions: the disposable power one implant plus 675 batteries were swelling and one exploded inside of a battery cover and cracked it.However, concerned batteries could not be retrieved for investigation.The investigation of the sonnet system revealed signs of oxidation most likely caused by high transpiration/moisture accumulation, which would not explain the reported problem, and several residuals of electrolyte leakage following the cell expansion.Batteries of the same batch were investigated by the supplier, and no specific cause could be determined for the observed issue.There were no abnormalities at production records and retaining samples visible.In previous cases seen by the supplier, the cell expansion happened due to an abnormal use e.G.Cell is being charged, or repeated use of empty or completely discharged cell.This is a final report.

• Brand Name: MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM
• Type of Device: EXTERNAL COMPONENT
• Manufacturer (Section D): MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH; innsbruck ; AU
• MDR Report Key: 10306428
• MDR Text Key: 199849071
• Report Number: 9710014-2020-00378
• Device Sequence Number: 1
• Product Code: MCM
• Combination Product (y/n): N
• PMA/PMN Number: P000025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 07/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: ZINC AIR BATTERIES
• Device Lot Number: 6338EXPSEP2022,1359EXPSEP2023
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 6 YR