FDA Adverse Event Injury Summary report: N

LAMITRODE 4 CHANNEL LEAD

MDR report key: 1834163 · Received September 13, 2010

Report

Report Number: 1627487-2010-02174
Event Type: Injury
Date Received: September 13, 2010
Date of Event: December 11, 2009
Report Date: December 14, 2009
Manufacturer: ADVANCED NEUROMODULATION SYSTEMS
Product Code: LGW
PMA / PMN Number: P010032
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MS, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

EVAL: DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECS AND NO ANOMALIES WERE FOUND. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. THIS MDR IS BEING SUBMITTED PAST THE 30 DAY REPORTING REQUIREMENT AS PART OF A RETROSPECTIVE REVIEW INITIATED IN RESPONSE TO AN FDA INSPECTION. A RETROSPECTIVE REVIEW OF THE COMPLAINT RECORD DETERMINED THAT ANS MISINTERPRETED THE MDR REGULATIONS IN THIS INSTANCE. 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 HER SCS SYSTEM INCLUDING TWO PADDLE LEADS AND AN IPG ON (B)(6)2009. IT WAS REPORTED THAT ONE OF THE LEADS HAD MIGRATED FROM ITS ORIGINAL POSITION AND WAS SURGICALLY REPOSITIONED. NO PRODUCT WAS RETURNED FOR ANALYSIS AS NO PRODUCT WAS EXPLANTED. F/U ON THE PT FOUND HIGH IMPEDANCES IMMEDIATELY POST-OPERATIVE; HOWEVER, THE HIGH IMPEDANCES WERE RESOLVED WITH REPROGRAMMING THE PT'S IPG. NO FURTHER INFO IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	LAMITRODE 4 CHANNEL LEAD	SPINAL CORD STIMULATION LEAD	LGW	ADVANCED NEUROMODULATION SYSTEMS	3240	2778456

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention