FDA Adverse Event Injury Summary report: N

UNKNOWN IMPLANTABLE NEUROSTIMULATOR

MDR report key: 4791351 · Received May 22, 2015

Report

Report Number: 3007566237-2015-01401
Event Type: Injury
Date Received: May 22, 2015
Date of Event: May 4, 2015
Report Date: May 4, 2015
Manufacturer: MEDTRONIC NEUROMODULATION
Product Code: LGW
PMA / PMN Number: P840001
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3878-45, SERIAL# (B)(4), EXPLANTED: (B)(6) 2015, PRODUCT TYPE LEAD. PRODUCT ID 97791, LOT# UNKNOWN, PRODUCT TYPE ACCESSORY. (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

Additional Manufacturer Narrative · 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative · 1

DEVICE EVALUATION: ANALYSIS OF THE LEAD FOUND THAT ¿ALL CONDUCTORS WERE BROKEN 14.9 CM FROM THE DISTAL END.¿ IT WAS NOTED THE CONDUCTOR WAS BROKEN AT THE ANCHOR SITE.

Description of Event or Problem · 1

IT WAS REPORTED THAT ALL ELECTRODES ON THE PAIN PATIENT¿S LEAD WERE FOUND TO HAVE HIGH IMPEDANCES OF ¿>40000¿ OHMS. IT WAS FURTHER REPORTED THERE WAS LEAD ¿BREAKAGE.¿ THE LEAD WAS SURGICALLY REPLACED AS A RESULT OF THE EVENT. THERE WAS NO PATIENT INJURY OR DEATH DUE TO THE EVENT AND THE PATIENT RECOVERED WITHOUT SEQUELA. A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION IS RECEIVED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
334678	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