FDA Adverse Event Injury Summary report: N

RESTORE SENSOR

MDR report key: 2854073 · Received December 3, 2012

Report

Report Number: 3004209178-2012-11048
Event Type: Injury
Date Received: December 3, 2012
Report Date: November 5, 2012
Manufacturer: MDT PUERTO RICO OPERATIONS CO
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

PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. (B)(4).

Additional Manufacturer Narrative · 1

ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (MODEL#37714, SERIAL#(B)(4)) FOUND NO ANOMALIES.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT HAD SEVEN "HIGH" IMPEDANCES, ON CONTACTS 9-15. THE LEAD WAS REMOVED AND "WIPED DOWN." THEN ONLY CONTACTS 12-15 HAD "HIGH" IMPEDANCES. THE PROCESS WAS REPEATED AND 14-15 WERE STILL "HIGH." THE LEAD WAS THEN HOOKED UP TO AN EXTERNAL NEUROSTIMULATOR AND ALL OF THE IMPEDANCES WERE "GOOD." THE LEAD WAS THEN HOOKED BACK UP TO THE DEVICE AND CONTACT 15 WAS STILL "OUT OF LIMITS." THE HEALTH CARE PROVIDER (HCP) ELECTED TO REPLACE THE DEVICE. THERE WERE NO PATIENT SYMPTOMS OR INJURIES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	RESTORE SENSOR	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	LGW	MDT PUERTO RICO OPERATIONS CO	37714

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention