FDA Adverse Event
Injury
Summary report: N
HIRES 90K
MDR report key: 2090858
·
Received May 10, 2011
Report
- Report Number
- 3006556115-2011-00237
- Event Type
- Injury
- Date Received
- May 10, 2011
- Date of Event
- March 8, 2011
- Report Date
- April 20, 2011
- Manufacturer
- ADVANCED BIONICS, LLC
- Product Code
- MCM
- PMA / PMN Number
- P960058
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- UNKNOWN
Narratives
Description of Event or Problem · 1
THE PATIENT REPORTEDLY EXPERIENCES PAIN AT THE IMPLANT SITE WHILE USING THE DEVICE. THE DOCTOR INSTRUCTED THE PATIENT TO REDUCE EXTERNAL EQUIPMENT WEAR TIME AND TO TAKE PAIN RELIEVER. THE PATIENT HAS CANCELLED RECENT APPOINTMENTS TO FOLLOW-UP WITH THE DOCTOR AND AUDIOLOGY. ADVANCED BIONICS IS IN THE PROCESS OF GATHERING MORE INFORMATION. ONCE MORE INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | HIRES 90K | COCHLEAR IMPLANT | MCM | ADVANCED BIONICS, LLC | CI-1400-01 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention |