FDA Adverse Event
Injury
Summary report: N
SYNERGY
MDR report key: 2256625
·
Received September 15, 2011
Report
- Report Number
- 6000032-2011-07859
- Event Type
- Injury
- Date Received
- September 15, 2011
- Report Date
- September 7, 2011
- Manufacturer
- MEL REL, HUMACAO
- 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
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A BURNING SENSATION FOLLOWING A FALL ON THE BUTTOCK, AT THE LOCATION OF THE IMPLANTABLE NEUROSTIMULATOR. THE DEVICE BATTERY DEPLETED THREE WEEKS AFTER THE FALL, AND IT WAS NOT POSSIBLE TO OBTAIN IMPEDANCE READINGS AT THAT TIME. THE NEUROSTIMULATOR WAS SUBSEQUENTLY REPLACED. THE PATIENT, THEN, RECEIVED "GOOD/NORMAL" STIMULATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNERGY | LGW | MEL REL, HUMACAO | 7427 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT# J0406294V| PROGRAMMER: MODEL 7435, LOT# NFT038613P| IMPLANTED:| EXTENSION: MODEL 7489, LOT# NHU045013V| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 7489, LOT# NHU045016V| LEAD: MODEL 3487A, LOT# J0406294V| IMPLANTED:| EXPLANTED: |