UNKNOWN EXTERNAL NEUROSTIMULATOR

MDR report key: 2823206 · Received November 7, 2012

Report

Report Number: 3007566237-2012-02656
Event Type: Malfunction
Date Received: November 7, 2012
Date of Event: October 9, 2012
Report Date: October 9, 2012
Manufacturer: MEDTRONIC NEUROMODULATION
Product Code: LGW
PMA / PMN Number: P840001
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NJ, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

(B)(4): ANALYSIS OF THE LEAD, MODEL #3778-60, SERIAL #(B)(4), FOUND NO ANOMALIES.

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THE LEAD WAS PLACED AND WHEN IT WAS TESTED THE PATIENT DID NOT FEEL STIMULATION. ANOTHER EXTERNAL NEUROSTIMULATOR WAS USED AND STILL THE PATIENT DID NOT FEEL STIMULATION. IMPEDANCES WERE IN THE 4000-5000 OHM RANGE. THE LEAD WAS MOVED TO A LOWER VERTEBRAL AREA AND STILL THE PATIENT COULD NOT FEEL STIMULATION. A NEW LEAD WAS USED AND THE PATIENT GOT 'GOOD' STIMULATION AT 4-5 VOLTS. NO PATIENT INJURY WAS REPORTED.

Description of Event or Problem · 1

ADDITIONAL INFORMATION RECEIVED REPORTED THAT A LEAD SHOWED HIGH IMPEDANCES AT IMPLANT AND A NEW LEAD WAS PLACED. IT WAS STATED THAT THE PATIENT DID NOT EXPERIENCE PARASTHESIA. IT WAS NOTED THAT THE HEALTHCARE PROFESSIONAL (HCP) REQUESTED A NEW LEAD TO BE PLACED. THE REPLACEMENT LEAD WORKED FINE. THERE WAS NO PATIENT INJURY AND THE PATIENT RECOVERED WITHOUT SEQUELA.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	UNKNOWN EXTERNAL NEUROSTIMULATOR	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	LGW	MEDTRONIC NEUROMODULATION	NEU_ENS_STIMULATOR

Patients

Seq	Age	Sex	Outcome	Treatment
1	00006 MO