FDA Adverse Event
Malfunction
Summary report: N
ACTIVA
MDR report key: 2948988
·
Received February 7, 2013
Report
- Report Number
- 3004209178-2013-01446
- Event Type
- Malfunction
- Date Received
- February 7, 2013
- Report Date
- January 17, 2013
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37642, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: EXTENSION: PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2011. PRODUCT TYPE: EXTENSION: PRODUCT ID 3389S-40, LOT# V801522, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD: PRODUCT ID 3389S-40, LOT# V742351, IMPLANTED: (B)(6) 2011. PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN A PATIENT TURNED HER DEVICE BACK ON SEVERAL MONTHS BEFORE THE REPORT, SHE FELT A JOLT GO THROUGH HER WHOLE BODY. THE DEVICE WAS CURRENTLY ON AND OKAY. THE REPORTER STATED THAT THE PATIENT HAD NO OTHER ISSUES WITH THE THERAPY AND IT WAS WORKING WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 53000 | ACTIVA | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MDT PUERTO RICO OPERATIONS CO | 37601 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |