FDA Adverse Event
Malfunction
Summary report: N
ENTERRA
MDR report key: 2040752
·
Received March 22, 2011
Report
- Report Number
- 3004209178-2011-02172
- Event Type
- Malfunction
- Date Received
- March 22, 2011
- Date of Event
- December 1, 2010
- Report Date
- March 14, 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
- ND, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPERIENCED SHOCKS IN THE ABDOMEN AFTER DEVICE SETTINGS WERE INCREASED. THE PROGRAMMER WAS PLACED OVER THE DEVICE AND ANALYSIS WAS PERFORMED WHILE THE DEVICE WAS ON. THE PT RECEIVED SHOCKS. THE BATTERY WAS NOTED AS SATISFACTORY AND THE SETTINGS WERE THEN DECREASED. THE ISSUE THEN RESOLVED.
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 | 42 YR | LEAD: MODEL 4351, LOT# NHT006995N| EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 4351, LOT# NHT006996N |