FDA Adverse Event
Malfunction
Summary report: N
ENTERRA
MDR report key: 1231236
·
Received November 13, 2008
Report
- Report Number
- 3004209178-2008-07433
- Event Type
- Malfunction
- Date Received
- November 13, 2008
- Report Date
- October 14, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LNQ
- PMA / PMN Number
- H990014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ND, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD A LOSS OF THERAPEUTIC EFFECT AFTER ATTENDING A NAVY GRADUATION THAT HAD MANY SECURITY SYSTEMS. IT'S POSSIBLE THAT THE PATIENT CAUGHT AN ILLNESS. SHE WAS TRAVELING IN FAIR CONDITION. FURTHER INFORMATION IS BEING REQUESTED FROM THE HCP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENTERRA | LNQ | MEDTRONIC PUERTO RICO OPERATIONS CO. | 3116 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 4351, LOT # NHT003439N| LEAD: MODEL 4351, LOT # NHT003438N| EXPLANTED: |