FDA Adverse Event Malfunction Summary report: N

RENEW RECEIVER

MDR report key: 1963872 · Received December 22, 2010

Report

Report Number: 1627487-2010-03852
Event Type: Malfunction
Date Received: December 22, 2010
Date of Event: November 23, 2010
Report Date: November 23, 2010
Manufacturer: ST. JUDE MEDICAL - NEUROMODULATION DIVISION
Product Code: GZB
PMA / PMN Number: K992946
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DEVICE HISTORY RECORD FOUND NONCONFORMANCES RELATED TO THE PRODUCT. HOWEVER, THE NONCONFORMANCES WERE IDENTIFIED AS COSMETIC ISSUES AND DID NOT AFFECT PRODUCT INTEGRITY; PRODUCT WAS REPLACED OR REWORKED AND APPROVED FOR USE. THE DHR ANOMALIES ARE NOT RELATED TO THE ALLEGED DEVICE FAILURE. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM HAS LIMITED INFO RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

Description of Event or Problem · 1

THE PT ((B)(6)) RECEIVED AN SCS SYSTEM ON (B)(6) 2007. IT WAS REPORTED THAT THE PT LOST STIMULATION. REPROGRAMMING EFFORTS WITH THE PATIENT'S TRANSMITTER AND A REPLACEMENT TRANSMITTER WERE UNSUCCESSFUL. THE PHYSICIAN PLANS TO EXPLANT AND REPLACE THE RECEIVER. A SURGERY DATE IS UNDETERMINED AT THIS TIME. NO FURTHER INFO IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	RENEW RECEIVER	SPINAL CORD STIMULATION RECEIVER	GZB	ST. JUDE MEDICAL - NEUROMODULATION DIVISION	3408	R47834

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention