FDA Adverse Event
Injury
Summary report: N
ENTERRA
MDR report key: 1972386
·
Received January 20, 2011
Report
- Report Number
- 3004209178-2011-00503
- Event Type
- Injury
- Date Received
- January 20, 2011
- Date of Event
- November 23, 2010
- Report Date
- January 12, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LNQ
- PMA / PMN Number
- H990014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.
Description of Event or Problem · 1
IT WAS ORIGINALLY REPORTED THAT THE PATIENT HAD THEIR NEUROSTIMULATOR REPLACED DUE TO NORMAL BATTERY DEPLETION. FOLLOW-UP INFORMATION INDICATED THAT THE DEVICE WAS EXPLANTED BECAUSE THE DEVICE HAD WORKED ITS WAY OUT THROUGH THE PATIENT'S SKIN. THE HEALTHCARE PROFESSIONAL HAD NOT HEARD FROM THE PATIENT SINCE AND HE ASSUMED THAT THEY WERE DOING WELL. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
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 | 62 YR | Required Intervention | LEAD: MODEL LEAD GES, LOT# UK6155583| EXPLANTED:| IMPLANTED: |