FDA Adverse Event Malfunction Summary report: N

LAMITRODE TRIPOL 16 LEAD, 60CM

MDR report key: 1791149 · Received August 6, 2010

Report

Report Number: 1627487-2010-01637
Event Type: Malfunction
Date Received: August 6, 2010
Date of Event: September 9, 2009
Report Date: September 23, 2009
Manufacturer: ADVANCED NEUROMODULATION SYSTEMS
Product Code: LGW
PMA / PMN Number: P010032
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NC, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

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 RETURNED INCOMPLETE AND COULD NOT BE FUNCTIONALLY TESTED. ONE LEAD SEGMENT IS KINKED WITH ALL WIRES BROKEN. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. ANS HAS LIMITED INFO RELATED TO THE PT¿S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT¿S HISTORY TO THE EVENT REPORTED. ANS DEFERS TO THE PT¿S PHYSICIAN REGARDING MEDICAL HISTORY.

Description of Event or Problem · 1

THE PT RECEIVED HIS SCS SYSTEM INCLUDING A PADDLE LEAD ON (B)(6) 2008. IT WAS REPORTED THAT THE PT WAS EXPERIENCING INTERMITTENT STIMULATION. X-RAYS SHOWED THAT THE LEAD HAD NOT MIGRATED AND THERE WERE NO VISIBLE FRACTURES. THE SYSTEM WAS REPLACED ON (B)(6) 2009. THE LEAD WAS TESTED DURING THE REPLACEMENT PROCEDURE AND CONTINUED TO SHOW INVALID CONTACTS. FOLLOW UP ON THE PT FOUND THAT NO FURTHER ISSUES HAVE BEEN REPORTED. THE EXPLANTED LEAD WAS RETURNED TO ANS FOR EVAL. NO FURTHER INFO IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	LAMITRODE TRIPOL 16 LEAD, 60CM	SPINAL CORD STIMULATION LEAD	LGW	ADVANCED NEUROMODULATION SYSTEMS	3219	171279

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention