UNKNOWN SPINAL CORD STIMULATOR

MDR report key: 1943661 · Received December 21, 2010

Report

Report Number: 3007566237-2010-10626
Event Type: Injury
Date Received: December 21, 2010
Date of Event: December 8, 2010
Report Date: December 8, 2010
Manufacturer: MEDTRONIC NEUROMODULATION
Product Code: LGW
PMA / PMN Number: P840001
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE FIRST TEST PERIOD WITH THE NEUROSTIMULATOR, THE PATIENT DID NOT GET THE STIMULATION IN THE CORRECT LOCATION. THE LEAD HAD BEEN IMPLANTED AT THE 11TH VERTEBRAE BUT THE SURGEON (AGAINST THE RECOMMENDATION OF THE COMPANY REPRESENTATIVE) DID NOT PLACE IN A MEDIAL LOCATION, BUT INSTEAD ON THE LEFT LATERAL SIDE. THE PATIENT THEN FELT THE STIMULATION ON THEIR LEFT SIDE IN HER FOOT, CALF, AND THIGH WHEN IT WAS NEEDED IN THE RIGHT LEG AND BUTTOCK. A SECOND NEUROSTIMULATOR WAS THEN IMPLANTED AND THE LEAD RELOCATED TO THE 10TH THORACIC VERTEBRAE. DURING THIS PROCEDURE, THE PHYSICIAN ATTEMPTED TO PASS BOTH EXTENSION CONNECTORS THROUGH THE TUNNELING TOOL WHICH DAMAGED THE INSULATION OF THE EXTENSION. THE EXTENSION WAS REPLACED. THE SECOND TEST PERIOD WITH THE NEUROSTIMULATOR WAS REPORTED AS SUCCESSFUL AND THE PATIENT FELT THE STIMULATION IN THE RIGHT BUTTOCK AND LEG. NO PATIENT INJURIES WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	UNKNOWN SPINAL CORD STIMULATOR		LGW	MEDTRONIC NEUROMODULATION	IPGNEURO	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	EXPLANTED:\| IMPLANTED:\| LEAD: MODEL 3998, LOT# UNKNOWN