FDA Adverse Event
Injury
Summary report: N
UNKNOWN NEUROSTIMULATOR
MDR report key: 2903551
·
Received January 9, 2013
Report
- Report Number
- 3007566237-2013-00079
- Event Type
- Injury
- Date Received
- January 9, 2013
- Date of Event
- December 10, 2012
- Report Date
- December 10, 2012
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID NEU_ADAPTOR_ACC, PRODUCT TYPE ACCESSORY; PRODUCT ID 3777-45, SERIAL# (B)(4), PRODUCT TYPE LEAD; PRODUCT ID 3708140, SERIAL# (B)(4), PRODUCT TYPE EXTENSION. (B)(4). (B)(6).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WERE HIGH IMPEDANCE VALUES MEASURE AFTER IMPLANT (5 OUT OF 8 ELECTRODES). IT WAS NOTED THAT THE VALUES WERE NORMAL PRIOR TO WOUND CLOSURE. A REVISION WAS PERFORMED ON (B)(6) 2012. THE ADAPTOR WAS TAKEN OFF AND NORMAL IMPEDANCE MEASUREMENTS WERE CONFIRMED. THE REPORTER BELIEVED THE PROBLEM TO BE WITH THE ADAPTOR. THE PATIENT OUTCOME WAS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 11599 | UNKNOWN NEUROSTIMULATOR | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |