FDA Adverse Event
Malfunction
Summary report: N
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
MDR report key: 2854245
·
Received November 27, 2012
Report
- Report Number
- 9710014-2012-00428
- Event Type
- Malfunction
- Date Received
- November 27, 2012
- Date of Event
- September 10, 2012
- Report Date
- November 23, 2012
- Manufacturer
- MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH
- Product Code
- MCM
- PMA / PMN Number
- P000025
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE SHOULD BE RETURNED TO (B)(6), THEN IT WILL BE SENT ONTO THE MFR, WHERE IT WILL BE EVALUATED. WHEN AVAILABLE, A DEVICE FAILURE ANALYSIS WILL BE SUBMITTED AS A FOLLOW-UP REPORT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT'S FAMILY CONTACTED THE AUDIOLOGIST AT THE CLINIC. TO REPORT THAT THE BATTERIES WITHIN THEIR BATTERY PACK HAD EXPLODED. THE CLINIC REPORTS SOME DIFFICULTIES IN OBTAINING THE EQUIPMENT FROM THE FAMILY AND IN VIEW OF THIS THEY ARE UNCERTAIN AS TO THE ACCURACY OF THE REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM | ZINC AIR BATTERIES | MCM | MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |