FDA Adverse Event
Malfunction
Summary report: N
ENTERRA
MDR report key: 2061785
·
Received March 30, 2011
Report
- Report Number
- 3004209178-2011-02400
- 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
- TX, 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 WHILE AT (B)(6), THE EMERGENCY ROOM, AND AT THE HOSPITAL. IT WAS NOTED THAT WHEN SHE SHOOK HANDS WITH PEOPLE THEY COULD FEEL THE SHOCKING. SHE ALSO HAD A LOSS OF THERAPEUTIC EFFECT AND A BURNING SENSATION IN HER STOMACH DURING AT THE SAME LOCATIONS. THE PATIENT HAD AN APPOINTMENT TO SEE HER PHYSICIAN AT THE END OF THIS MONTH. 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 | 53 YR | LEAD: MODEL 4351, LOT# NHT011029N| EXPLANTED:| LEAD: MODEL 4351, LOT# NHT011030N| EXPLANTED:| IMPLANTED:| IMPLANTED: |