FDA Adverse Event
Injury
Summary report: N
ACTIVA PC
MDR report key: 2250629
·
Received September 9, 2011
Report
- Report Number
- 3004209178-2011-07673
- Event Type
- Injury
- Date Received
- September 9, 2011
- Date of Event
- August 1, 2011
- Report Date
- August 18, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAD A REVISION ONE WEEK PRIOR DUE TO HIS IMPLANTABLE NEUROSTIMULATOR (INS) MOVING UNDER HIS ARMPIT. THE PT EXPERIENCED A SHOCKING SENSATION FROM HIS INS WHILE HE WAS DRIVING, AND HIS BATTERY PACK MOVED NEXT TO HIS OTHER BATTERY PACK AT WHICH TIME HE WAS "SHOCKED IN HIS FACE." ADD'L INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT IF INFO BECOMES AVAILABLE. SEE ALSO MFR REPORT # 3004209178-2011-07671. IN ADDITION, SEE MFR REPORTS #3004209178-2011-07668 AND 3004209178-2011-07669 AND FOR SUBSEQUENT REVISION ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACTIVA PC | MHY | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 37601 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention | IMPLANTABLE NEURO STIMULATOR: MODEL 37601,| EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| LOT # NKM706437H| EXPLANTED:| EXTENSION: MODEL 7495, LOT # XR0025764N| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3382, LOT # L33314| PROGRAMMER: MODEL 37642, LOT # NJZ107295N| EXTENSION: MODEL 37085, LOT # NKN011508V| IMPLANTED:| LEAD: MODEL 3387S, LOT # V042082 |