FDA Adverse Event
Malfunction
Summary report: N
SYNERGY
MDR report key: 2023074
·
Received February 24, 2011
Report
- Report Number
- 3004209178-2011-01402
- Event Type
- Malfunction
- Date Received
- February 24, 2011
- Date of Event
- February 3, 2011
- Report Date
- February 8, 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
- CA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
RECEIVED INFORMATION THE PATIENT EXPERIENCED INCREASED RADIATING RIGHT LEG PAIN. INTERROGATION OF THE DEVICE WAS DONE AND SOME ELECTRODES WERE FOUND TO BE OUT OF RANGE. REPROGRAMMING WAS DONE WITH IMPROVED STIMULATION PARESTHESIA. THIS EVENT IS CONSIDERED ONGOING. AS ADDITIONAL INFORMATION BECOMES AVAILABLE A FOLLOW UP REPORT WILL BE SENT.
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 | 62 YR | Female | EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED:| EXPLANTED: NA| EXTENSION: MODEL 37082, LOT# NKB0006848| EXTENSION: MODEL 37082, LOT# NKB000686N| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED: | LEAD MODEL 3487A, LOT# J0406563V| LEAD: MODEL 3487A, LOT# J0417671V| LEAD: MODEL 3487A, LOT# J0417780V| PROGRAMMER: MODEL 37742, LOT# NJD021939N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT# J0417671V| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXTENSION: MODEL 37082, LOT# NKB0006848| EXPLANTED:| EXTENSION: MODEL 37082, LOT# NKB000686N| EXPLANTED:| PROGRAMMER: MODEL 37742, LOT# NJD021939N| LEAD: MODEL 3487A, LOT# J0417780V| IMPLANTED: |