FDA Adverse Event Injury Summary report: N

OCTRODE PERCUTANEOUS LEAD

MDR report key: 1622091 · Received February 24, 2010

Report

Report Number: 1627487-2009-00339
Event Type: Injury
Date Received: February 24, 2010
Date of Event: June 17, 2008
Report Date: June 19, 2008
Manufacturer: ADVANCED NEUROMODULATION SYSTEMS, INC.
Product Code: LGW
PMA / PMN Number: P010032
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NC, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

DEVICE 1 OF 2. 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

DEVICE 1 OF 2. REFERENCE MFR'S REPORT 1627487-2009-00340. THE PT RECEIVED HER SCS SYSTEM CONSISTING OF AN IPG AND 2 LEADS ON (B) (6) 2008. IT WAS REPORTED THAT SHORTLY THEREAFTER THE LEADS HAD MIGRATED. THE PT DECLINED A REVISION PROCEDURE AND INSTEAD ASKED FOR THE SYSTEM TO BE REMOVED. DURING THE EXPLANT PROCEDURE ON (B) (6) 2008, IT WAS REPORTED THAT THE LEADS WERE LOCATED UNDERNEATH THE IPG.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OCTRODE PERCUTANEOUS LEAD	SPINAL CORD STIMULATION LEAD	LGW	ADVANCED NEUROMODULATION SYSTEMS, INC.	3189	97174

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention