FDA Adverse Event
Malfunction
Summary report: N
ACTIVA PC
MDR report key: 1970993
·
Received January 6, 2011
Report
- Report Number
- 3004209178-2011-00142
- Event Type
- Malfunction
- Date Received
- January 6, 2011
- Date of Event
- January 1, 2010
- Report Date
- December 22, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- 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
THE IMPEDANCE MEASUREMENTS WERE ALL ABOVE 10,000 OHMS EXCEPT WITH CONTACT 2 WHICH WAS 1500 OHMS. THE PT WAS PROGRAMMED WITH 1-2 CONTACTS AND ITS IMPEDANCE MEASUREMENT WAS 9143 OHMS. ADD'L INFO HAS BEEN REQUESTED.
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 | 42 YR | IMPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT# J0237085V| IMPLANTED:| EXTENSION: MODEL 7495-51, LOT# XR0092008N| EXPLANTED:| EXPLANTED:| MODEL 37601, LOT# NKM700706H| EXPLANTED:| EXTENSION: MODEL 7482, LOT# NHU001295V| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT# J0454876V| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR:| EXPLANTED: |