FDA Adverse Event
Injury
Summary report: N
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
MDR report key: 4210656
·
Received October 29, 2014
Report
- Report Number
- 3007566237-2014-03157
- Event Type
- Injury
- Date Received
- October 29, 2014
- Report Date
- September 30, 2014
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED REPORTED HE PATIENT HAD A BACK SURGERY AND IMPLANT SURGERY IN 2010. AFTER THE BACK SURGERY, FLUID BUILT UP AND ¿DROWNED THE IMPLANTABLE NEUROSTIMULATOR (INS)¿ AND THE PATIENT COULD NOT CONNECT TO THE INS. IN 2012, THEY HAD TO DRAIN THE FLUID AND ¿PUT IN A NEW INS.¿
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 693604 | UNKNOWN IMPLANTABLE NEUROSTIMULATOR | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC NEUROMODULATION | NEU_INS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00054 YR | Required Intervention |