FDA Adverse Event
Malfunction
Summary report: N
SYNERGY
MDR report key: 1994354
·
Received January 14, 2011
Report
- Report Number
- 3004209178-2011-00375
- Event Type
- Malfunction
- Date Received
- January 14, 2011
- Date of Event
- January 1, 2011
- Report Date
- January 4, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- 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 PT EXPERIENCED A LOSS OF THERAPEUTIC. HE HAD GOOD STIMULATION UNTIL (B)(6) 2011 WHEN HE FELT A SURGE IN RIGHT SIDE OF ABDOMEN. HE NO LONGER RECEIVED STIMULATION IN LEFT BACK AND LEG. THE LEAD IMPEDANCE MEASUREMENTS WERE IN NORMAL RANGE. HE WAS PREVIOUSLY PROGRAMMED TO 2-3 BUT WHEN STIMULATION WAS TURNED UP TO 10V HE FELT NOTHING. COMBINATION 1-3 WAS TRIED AND SOME STIMULATION WAS FELT BUT THEN IT WAS LOST. HE TENDS TO USE A HIGHER SETTING OF 8V+. ADDITIONAL INFO HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNERGY | LGW | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 7427 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | IMPLANTED:| EXPLANTED:| EXTENSION: MODEL 7495-51, LOT# XR0019479N| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3888, LOT# L33090| UNK CONVERSION TYPE: MODEL 3550-09, LOT# N169349 |