FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
MDR report key: 3133675
·
Received May 29, 2013
Report
- Report Number
- 3007566237-2013-01756
- Event Type
- Malfunction
- Date Received
- May 29, 2013
- Report Date
- May 7, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LNQ
- PMA / PMN Number
- H990014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT HAD A BLADDER PROBLEM AND THE DEVICE NEVER WORKED. NO FURTHER INFORMATION WAS REPORTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 234287 | UNKNOWN IMPLANTABLE NEUROSTIMULATOR | INTESTINAL STIMULATOR | LNQ | MEDTRONIC NEUROMODULATION | NEU_ENTERRA_INS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |