FDA Adverse Event
Malfunction
Summary report: N
ENTERRA
MDR report key: 2061783
·
Received March 30, 2011
Report
- Report Number
- 3004209178-2011-02402
- Event Type
- Malfunction
- Date Received
- March 30, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 21, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LNQ
- PMA / PMN Number
- H990014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, 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 SHOCKING SENSATION AND THAT HER NEUROSTIMULATOR WAS PROTRUDING AND "STANDING UP". THE SHOCKING HAD BEEN OCCURRING FOR ABOUT A WEEK AND THERE WAS NO ACCIDENT OR INCIDENT ASSOCIATED WITH THE EVENT. IT WAS NOTED THAT SHE HAD AN INCIDENT IN (B)(6) 2010 WHERE SHE WOKE UP IN HER SLEEP AND HER DEVICE HAD MOVED AND STARTED TO "STICK OUT". ADDITIONAL INFORMATION WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENTERRA | LNQ | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 3116 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 39 YR | LEAD: MODEL 4351, LOT# NHT011108N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 4351, LOT# NHT010565N| IMPLANTED:| IMPLANTED:| LEAD: MODEL 4351, LOT# NHT011110N| EXPLANTED:| EXPLANTED: |