FDA Adverse Event
Malfunction
Summary report: N
ENTERRA
MDR report key: 1994348
·
Received January 14, 2011
Report
- Report Number
- 3004209178-2011-00378
- Event Type
- Malfunction
- Date Received
- January 14, 2011
- Date of Event
- December 1, 2010
- Report Date
- January 10, 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
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT WENT THROUGH A METAL DETECTOR ABOUT TWO WEEKS AGO AND SINCE THAT TIME FELT AN INTERMITTENT SHOCKING SENSATION. THE PATIENT SAID THAT IT FELT LIKE A FINGER WAS BEING STUCK INTO AN ELECTRICAL SOCKET. 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 | 39 YR | LEAD: MODEL 4351, LOT# NHT012323N| IMPLANTED:| LEAD: MODEL 4351, LOT# NHT012322N| EXPLANTED:| IMPLANTED:| EXPLANTED: |