FDA Adverse Event Injury Summary report: N

PRIMEADVANCED

MDR report key: 2900410 · Received January 7, 2013

Report

Report Number: 3004209178-2013-00273
Event Type: Injury
Date Received: January 7, 2013
Report Date: December 17, 2012
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: LGW
PMA / PMN Number: P840001
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: OK, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4): PRODUCT ID 748951, SERIAL# (B)(4), IMPLANTED: 2003-(B)(6), PRODUCT TYPE EXTENSION PRODUCT ID 74001, LOT# N311223, IMPLANTED: 2012-(B)(6), PRODUCT TYPE ADAPTER PRODUCT ID 37744, SERIAL# (B)(4),PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 3587A, LOT# L91984, IMPLANTED: 2003-(B)(6), PRODUCT TYPE LEAD. (B)(4).

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

IT WAS REPORTED STIMULATION STOPPED WORKING APPROXIMATELY ONE MONTH PRIOR. THE PATIENT HAD NOT SEEN THEIR HEALTH CARE PROVIDER (HCP) TO HAVE THEIR DEVICE EVALUATED. IT WAS ALSO NOTED THE PATIENT NOTICED THEIR POCKET SITE WAS "OOZING" 3-4 DAYS PRIOR TO REPORT. FOLLOW UP REPORTED THE PATIENT WAS SEEING THEIR HEALTH CARE PROVIDER THE FOLLOWING DAY FOR POSSIBLE BATTERY SITE INFECTION. IT WAS UNKNOWN IF THE IMPLANTABLE NEUROSTIMULATOR (INS) WOULD BE EXPLANTED.

Description of Event or Problem · 1

ADDITIONAL INFORMATION STATED THAT THE PATIENT HAD THEIR DEVICE EXPLANTED DUE TO INFECTION AFTER POCKET EROSION. THE EXPLANT WAS REP ORTEDLY ON (B)(6) 2012. THE PATIENT RECOVERED AND NO LONGER HAD AN INFECTION. THE PATIENT HAD A RETURN OF SYMPTOMS WITHOUT THE DEVICE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
6596	PRIMEADVANCED	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	LGW	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	37702

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention