FDA Adverse Event
Injury
Summary report: N
MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM
MDR report key: 1983916
·
Received February 4, 2011
Report
- Report Number
- 9710014-2011-00043
- Event Type
- Injury
- Date Received
- February 4, 2011
- Date of Event
- January 31, 2011
- Report Date
- February 1, 2011
- Manufacturer
- MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH
- Product Code
- MCM
- PMA / PMN Number
- P000025
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE HAS BEEN EXPLANTED AND SHOULD BE RETURNED TO THE MANUFACTURER FOR EVALUATION. 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 SUFFERED FROM A CONSTANT EPILEPTIC CRISIS WHILE AWAKE. THE PT HAS BEEN IMPLANTED BILATERALLY. THE BRAIN REGION NEEDED TO BE EVALUATED AND WAS JUST BEHIND THE IMPLANT AREA AND WOULD BE AFFECTED BY DARK MRI ARTIFACT. AS NO OTHER DIAGNOSTIC TOOL OTHER THAN MRI WAS AVAILABLE TO OBSERVE THE BILATERAL TEMPORAL EPILEPSY PRIOR TO NEUROSURGERY, ON (B)(6) 2011, BOTH COCHLEA IMPLANTS WERE EXPLANTED, TO ENABLE A BILATERAL HIGH RESOLUTION MRI OF BOTH TEMPORAL LOBULES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM | COCHLEAR IMPLANT | MCM | MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH | PULSAR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 YR | Required Intervention |