FDA Adverse Event
Injury
Summary report: N
ENTERRA
MDR report key: 2201718
·
Received August 5, 2011
Report
- Report Number
- 3004209178-2011-06100
- Event Type
- Injury
- Date Received
- August 5, 2011
- Report Date
- July 12, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LNQ
- PMA / PMN Number
- H990014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ANALYSIS OF IMPLANTABLE NEUROSTIMULATOR (INS) MODEL 3116 (B)(4) DETERMINED THE INS WAS FUNCTIONALLY OKAY WITH NO SIGNIFICANT ANOMALIES. FOREIGN MATTER WAS IN THE CONNECTOR PORT AND GOOD, STABLE OUTPUT WAS OBSERVED ON EACH ELECTRODE PAIR.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS NO LONGER PROVIDING THERAPEUTIC EFFECT. DURING EXPLANT, THERE APPEARED TO BE FLUID, ETC IN THE HEADER BLOCK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENTERRA | LNQ | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 3116 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | EXPLANTED:| EXPLANTED:| LEAD: MODEL 4351, LOT# NHT000366N| LEAD: MODEL 4351, LOT# NHT000389N| IMPLANTED:| IMPLANTED: |