FDA Adverse Event
Injury
Summary report: N
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
MDR report key: 3771311
·
Received April 24, 2014
Report
- Report Number
- 3007566237-2014-01138
- Event Type
- Injury
- Date Received
- April 24, 2014
- Report Date
- January 12, 2012
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE INFECTION WAS PREVIOUSLY REPORTED IN MANUFACTURING REPORT # 9614453-2011-08927, BUT UPON FURTHER REVIEW, WILL NOW BE CAPTURED IN THIS MANUFACTURING REPORT NUMBER. ANY ADDITIONAL INFORMATION WILL BE SENT UNDER THIS REPORT NUMBER. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE OLD NEUROSTIMULATOR AND EXTENSION, LOCATED ON THE RIGHT SIDE OF THE PATIENT, WERE REPLACED ON 2011-(B)(6) BECAUSE OF AN INFECTION. IT WAS DECIDED TO IMPLANT THE NEW NEUROSTIMULATOR AND EXTENSION ON THE LEFT SIDE, BUT THE SAME LEAD WAS USED. IT WAS NOTED THE IMPLANT WENT OK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 249381 | UNKNOWN IMPLANTABLE NEUROSTIMULATOR | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |