FDA Adverse Event
Injury
Summary report: N
ENTERRA
MDR report key: 3927538
·
Received July 10, 2014
Report
- Report Number
- 3007566237-2014-01931
- Event Type
- Injury
- Date Received
- July 10, 2014
- Report Date
- March 7, 2002
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LNQ
- PMA / PMN Number
- H990014
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID 4351, SERIAL # UNKNOWN, PRODUCT TYPE LEAD; PRODUCT ID 4351, SERIAL # UNKNOWN, PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS AN UNKNOWN PATIENT THAT HAD ¿SIMILAR COMPLAINTS¿ TO A PATIENT. IT WAS NOTED THAT DEVICE OF THE UNKNOWN PATIENT WAS TO BE REMOVED. SEE MANUFACTURING REPORT #S 6000032-2014-00141, 6000032-2014-00138, <(>&<)> 6000032-2014-00139 FOR RELATED PATIENT WITH PAIN. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT YET RECEIVED AT THE TIME OF THE REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 405269 | ENTERRA | INTESTINAL STIMULATOR | LNQ | MEDTRONIC NEUROMODULATION | 3116 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |