FDA Adverse Event Malfunction Summary report: N

OCTRODE 3/4 PERCUTANEOUS LEADS

MDR report key: 1842408 · Received August 31, 2010

Report

Report Number: 1627487-2010-02542
Event Type: Malfunction
Date Received: August 31, 2010
Date of Event: July 19, 2010
Report Date: August 3, 2010
Manufacturer: ADVANCED NEUROMODULATION SYSTEMS, INC.
Product Code: LGW
PMA / PMN Number: P010032
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: IN, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

EVAL - METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: ALTHOUGH THE PRODUCTS HAVE BEEN RETURNED, NO ANALYSIS HAS BEEN COMPLETED ON THEM YET. 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

DEVICE 2 OF 2. PLEASE SEE MFG REPORT #1627487-2010-01990 FOR DEVICE 1. ON (B)(6) 2009, THE PT WAS IMPLANTED WITH AN SCS SYSTEM. THE PT'S STIMULATION NO LONGER COVERED HER PAIN PATTERN; SHE WAS INSTEAD EXPERIENCING STOMACH STIMULATION. THE LEAD APPEARS TO HAVE MIGRATED. THE PT ALSO DID NOT CHARGE HER IPG FOR APPROX NINE MONTHS. WHEN SHE MET WITH THE REP, THEY WERE UNABLE TO COMMUNICATE WITH THE IPG AFTER TRYING BOTH A PROGRAMMER AND A CHARGER. AN EXPLANT WAS SCHEDULED FOR (B)(6) 2010. THE LEADS WERE TESTED INTRA-OPERATIVELY AND ONE GAVE HIGH IMPEDANCE READINGS. IT WAS REPLACED ALONG WITH THE PT'S IPG.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OCTRODE 3/4 PERCUTANEOUS LEADS	SPINAL CORD STIMULATION LEAD	LGW	ADVANCED NEUROMODULATION SYSTEMS, INC.	3186	2838250

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other