FDA Adverse Event
Injury
Summary report: N
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
MDR report key: 4223052
·
Received November 4, 2014
Report
- Report Number
- 3007566237-2014-03217
- Event Type
- Injury
- Date Received
- November 4, 2014
- Date of Event
- October 15, 2014
- Report Date
- October 15, 2014
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCT: PRODUCT ID NEU_UNKNOWN_EXT, SERIAL # UNKNOWN, PRODUCT TYPE EXTENSION. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THERE WAS AN EXTENSION BREAK. IMPEDANCE TESTING WAS DONE AND HIGH IMPEDANCES WERE FOUND. THERE WERE NO PATIENT SYMPTOMS REPORTED. THE ISSUE WAS RESOLVED AFTER THE DEVICE WAS EXPLANTED AND REPLACED BY ANOTHER PRODUCT. NO OUTCOME WAS REPORTED REGARDING THIS EVENT. FOLLOW UP HAS BEEN CONDUCTED, AND IF FURTHER INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
Description of Event or Problem · 1
ADDITIONAL INFORMATION INDICATED THE PATIENT WAS RECEIVING EFFECTIVE THERAPY FOLLOWING THE EXTENSION REPLACEMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 707933 | UNKNOWN IMPLANTABLE NEUROSTIMULATOR | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | MEDTRONIC NEUROMODULATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |