SYNERGY VERSITREL

MDR report key: 2863416 · Received December 10, 2012

Report

Report Number: 3004209178-2012-11339
Event Type: Injury
Date Received: December 10, 2012
Report Date: November 15, 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: MN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

PRODUCT ID, 7495-51 LOT# SERIAL# (B)(4), PRODUCT TYPE EXTENSION PRODUCT ID, 7435 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID, 3888-28 LOT# L42586, IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID, 3550-09 LOT# N083511, PRODUCT TYPE ACCESSORY. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT WAS TO HAVE THE DEVICE AND POTENTIALLY THE LEAD AND/OR EXTENSION REPLACED. IT WAS STATED THAT THE PATIENT HAD "BAD" IMPEDANCES AT THE DATE OF THIS REPORT. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS UNAVAILABLE AT THE DATE OF THIS REPORT. ANY ADDITIONAL INFORMATION WILL BE INCLUDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem · 1

FOLLOW UP REPORTED HIGH IMPEDANCES NEVER RESOLVED. IT WAS NOTED REPROGRAMMING WAS DONE TO MAKE SURE THE PATIENT RECEIVED "GOOD" COVERAGE IN THEIR HAND. IT WAS NOTED THE PATIENT'S LEADS AND EXTENSIONS WERE OVER TEN YEARS OLD AND TO THE KNOWLEDGE OF THE PATIENT "THE COVERAGE HAD ALWAYS BEEN THE SAME." THE REASON FOR THE REPLACEMENT WAS END OF LIFE FOR THE BATTERY. PATIENT IS CURRENTLY "HAPPY" WITH DEVICE AND "COULDN'T LIVE WITHOUT THE THERAPY."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SYNERGY VERSITREL	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	LGW	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	7427V-NP

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention