FDA Adverse Event
Injury
Summary report: N
IMPLANTABLE NEUROSTIMULATOR
MDR report key: 2925154
·
Received January 22, 2013
Report
- Report Number
- 3007566237-2013-00243
- Event Type
- Injury
- Date Received
- January 22, 2013
- Report Date
- December 13, 2012
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE EXTENSION WAS "EXTREMELY TWISTED" DURING AN IMPLANTABLE NEUROSTIMULATOR (INS) REPLACEMENT SURGERY. THE EXTENSION WAS CONNECTED TO THE NEW INS, BUT NO STIMULATION EFFECT COULD BE ACHIEVED. THE IMPEDANCES WERE ALSO REPORTED AS "TOO HIGH." THE EXTENSION WAS PLANNED TO BE REPLACED DURING AN EXPLANT PROCEDURE SCHEDULED FOR (B)(6) 2013. NO SYMPTOMS OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT. THE PATIENT'S STATUS WAS REPORTED AS NO INJURY AND NO ADVERSE EVENT. NO FURTHER INFORMATION WAS REPORTED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 30769 | 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 |