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

Model Number DACAPO POWERPACK

Device Problem Fluid/Blood Leak (1250)

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

Event Type  malfunction  

Manufacturer Narrative

The device has been returned to (b)(4) where it will be evaluated.When available, a device failure analysis will be submitted as a follow-up report.

Event Description

A broken and leaking dacapo powerpack has been received at service _ repair.Reportedly nobody got in contact with the leaking electrolyte.

Manufacturer Narrative

Conclusion: the returned devices were visually inspected upon arrival.Mechanically damaged housings were observed.The observed damages did not allow electrical testing to be conducted.The damages to the battery housing were clearly the reason for the malfunction of the device returned by the end-user.It is very likely, that bulging of the housing caused the observed damages and indicates that the devices were not refreshed/used for a long period of time.The contacts seem to be oxidized by the leaking electrolyte.This is a final report.

Event Description

A broken and leaking dacapo powerpack has been received at service repair.Reportedly there was no contact with the leaking electrolyte or any injury sustained.

• 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: 10441155
• MDR Text Key: 204020792
• Report Number: 9710014-2020-00458
• 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: 09/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DACAPO POWERPACK
• Device Lot Number: SN: 0805A219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR