FDA Adverse Event
Injury
Summary report: N
UNKNOWN IMPLANTABLE NEUROSTIMULATOR
MDR report key: 3811404
·
Received May 15, 2014
Report
- Report Number
- 3007566237-2014-01318
- Event Type
- Injury
- Date Received
- May 15, 2014
- Report Date
- April 25, 2014
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT HAD UNDERGONE TWO REVISION PROCEDURES. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME OF REPORT. ADDITIONAL INFORMATION STATED THE PATIENT ¿RIPPED THE BATTERY PACK OUT OF HIS BACK¿ AND REQUIRED A REVISION SURGERY DUE TO THIS. THE PATIENT NOTED IT WAS HIS FAULT. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 290904 | 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 |