FDA Adverse Event
Malfunction
Summary report: N
ENTERRA
MDR report key: 1980008
·
Received January 24, 2011
Report
- Report Number
- 3004209178-2011-00560
- Event Type
- Malfunction
- Date Received
- January 24, 2011
- Date of Event
- January 1, 2011
- Report Date
- January 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
- PA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN THE PT'S DOCTOR CHECKED THE DEVICE, IT WAS OFF. THE IMPLANT HAD TURNED OFF WITHOUT THE PT'S KNOWLEDGE. THE SOURCE OF THE EXPOSURE THAT MAY HAVE TURNED THE DEVICE OFF WAS UNK. THE PT REPORTED A LOSS OF THERAPEUTIC EFFECT, AND FELT NO STIMULATION SENSATION FOLLOWING SOME TYPE OF ENVIRONMENTAL EXPOSURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
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 | 62 YR | LEAD: MODEL 4351, LOT# NHT012571N| LEAD: MODEL 4351, LOT# NHT012570N| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED: |