FDA Adverse Event
Malfunction
Summary report: N
ACTIVA PC
MDR report key: 2182210
·
Received July 7, 2011
Report
- Report Number
- 3004209178-2011-05164
- Event Type
- Malfunction
- Date Received
- July 7, 2011
- Date of Event
- January 1, 2011
- Report Date
- June 13, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT EXPERIENCED A TINGLING SENSATION AT THE IMPLANTABLE NEUROSTIMULATOR SITE. THE TINGLING BEGAN A FEW MONTHS AGO FOLLOWING A FALL. ADD'L INFO HAS BEEN REQUESTED. A F/U REPORT WILL BE SENT IF ADD'L INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACTIVA PC | MHY | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 37601 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR | EXTENSION: MODEL 37085, LOT# NKN014097V| EXPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT# V621406| EXTENSION: MODEL 37085, LOT# NKN014178V| PROGRAMMER: MODEL 37642, LOT# NJZ109795N| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT# V621406| EXPLANTED:| EXPLANTED:| IMPLANTED: |