FDA Adverse Event Injury Summary report: N

OCTRODE LEAD

MDR report key: 1870526 · Received September 29, 2010

Report

Report Number: 1627487-2010-01784
Event Type: Injury
Date Received: September 29, 2010
Date of Event: March 3, 2009
Report Date: March 3, 2009
Manufacturer: ADVANCED NEUROMODULATION SYSTEMS
Product Code: LGW
PMA / PMN Number: P010032
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: OR, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

(B)(4). RESULTS: LEAD SEVERELY KINKED WITH ALL WIRES BROKEN. NO TESTING PERFORMED ON INCOMPLETE LEADS. (B)(4). 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 2 OF 2. REFERENCE MANUFACTURER'S REPORT: 1627487-2010-01783. THE PT RECEIVED HER SCS SYSTEM ON AN UNK DATE. IT WAS REPORTED THAT THE PT WAS EXPERIENCING OVERSTIMULATION. EXAMINATION OF THE PT'S SYSTEM FOUND A LEAD FRACTURE. IN ADDITION, THE PT HAD DEVELOPED A BLISTER OVER THE IPG IMPLANT SITE. THE LEADS AND IPG WERE EXPLANTED AND REPLACED ON (B)(6) 2009. FOLLOW UP ON THE PT FOUND NO OTHER ISSUES REPORTED. THE EXPLANTED LEADS AND IPG WERE RETURNED TO THE MANUFACTURER FOR ANALYSIS. NO FURTHER INFO IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OCTRODE LEAD	SPINAL CORD STIMULATION LEAD	LGW	ADVANCED NEUROMODULATION SYSTEMS	3186

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention