FDA Adverse Event Malfunction Summary report: N

QUATTRODE PERCUTANEOUS LEAD

MDR report key: 1870685 · Received September 29, 2010

Report

Report Number: 1627487-2010-02258
Event Type: Malfunction
Date Received: September 29, 2010
Date of Event: May 5, 2009
Report Date: May 5, 2009
Manufacturer: ADVANCED NEUROMODULATION SYSTEMS
Product Code: LGW
PMA / PMN Number: P010032
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KY, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

EVALUATION, METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES WERE FOUND. LEAD HAD KINKS IN MULTIPLE LOCATIONS. THE LEAD HAD BROKEN WIRES AND DID NOT PASS FUNCTIONAL TESTING. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. (B)(4). ANS HAS LIMITED INFORMATION 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. ANS DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

Description of Event or Problem · 1

DEVICE 1 OF 3: REFERENCE MANUFACTURER REPORT: 1627487-2010-02259 & 1627487-2010-02260. THE PT RECEIVED HIS SCS SYSTEM ON (B)(6) 2008 CONSISTING OF 2 PERCUTANEOUS LEADS, A LEAD EXTENSION, AND AN IPG. IT WAS REPORTED THAT THE PT LOST STIMULATION THERAPY APPROXIMATELY A MONTH LATER. THE TWO LEADS AND EXTENSION WERE EXPLANTED AND REPLACED ON (B)(6) 2008. THE EXPLANTED LEADS AND EXTENSION WERE RETURNED TO THE MANUFACTURER FOR EVAL. NO FURTHER INFO IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	QUATTRODE PERCUTANEOUS LEAD	SPINAL CORD STIMULATION LEAD	LGW	ADVANCED NEUROMODULATION SYSTEMS	3146	R172690

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention