FDA Adverse Event Malfunction Summary report: N

RESTORE RECHARGABLE NEUROSTIMULATOR

MDR report key: 1872612 · Received October 12, 2010

Report

Report Number: 3004209178-2010-07894
Event Type: Malfunction
Date Received: October 12, 2010
Date of Event: August 24, 2010
Report Date: August 24, 2010
Manufacturer: MDT PUERTO RICO OPERATIONS CO., JUNCOS
Product Code: LGW
PMA / PMN Number: P840001
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). THE DEVICE HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE. REASON FOR LATE MDR DUE TO IMPLEMENTATION OF PROCESS IMPROVEMENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT, DURING AN IMPLANT PROCEDURE, THE PT'S IMPLANTABLE NEUROSTIMULATOR (INS) SHOWED IMPEDANCES OF >3,600 OHMS WHEN THE LEADS WERE PLUGGED IN TO THE INS. WHEN THE LEADS WERE THEN PLUGGED IN TO THE SNAP-LID, THE IMPEDANCES WERE NORMAL. A NEW INS WAS THEN USED, WITH HIGH IMPEDANCES STILL REPORTED. TROUBLESHOOTING SUGGESTED THE IMPEDANCES WOULD RETURN TO NORMAL AFTER FLUID AND/OR AIR WAS ALLOWED TO DISPERSE FROM THE EPIDURAL SPACE. ONE HOUR POST-OP, THE PT'S DEVICE WAS PROGRAMMED AND IMPEDANCE READINGS WERE REPORTEDLY WITHIN NORMAL LIMITS AND THE PT WAS RECEIVING "ADEQUATE STIMULATION." THE PT RECOVERED WITHOUT SEQUELA. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	RESTORE RECHARGABLE NEUROSTIMULATOR		LGW	MDT PUERTO RICO OPERATIONS CO., JUNCOS	37711	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	51 YR			EXPLANTED:\| LEAD: MODEL 3778, LOT# V481240024\| LEAD: MODEL 3778, LOT# V490093026\| EXPLANTED:\| IMPLANTED:\| IMPLANTED: