FDA Adverse Event
Injury
Summary report: N
ACTIVA PC
MDR report key: 1983999
·
Received February 7, 2011
Report
- Report Number
- 3004209178-2011-00946
- Event Type
- Injury
- Date Received
- February 7, 2011
- Date of Event
- January 1, 2010
- Report Date
- January 21, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
RECEIVED INFO THE PT HAD HIS DEVICE SYSTEM EXPLANTED DUE TO INFECTION. ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.
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 | 64 YR | Required Intervention | IMPLANTED:| STIM ACCESSORY: MODEL 37092, LOT # 238250001| EXPLANTED:| EXTENSION: MODEL 37085, LOT # NKN010018V| IMPLANTED:| LEAD: MODEL 3389S-40, LOT # V483065| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 37085, LOT # NKN009588V| LEAD: MODEL 3389S-40, LOT # V483065| IMPLANTED: |