FDA Adverse Event Malfunction Summary report: N

QUATTRODE 4 PERCUTANEOUS LEAD

MDR report key: 1646842 · Received March 24, 2010

Report

Report Number: 1627487-2010-00177
Event Type: Malfunction
Date Received: March 24, 2010
Date of Event: February 19, 2010
Report Date: February 25, 2010
Manufacturer: ADVANCED NEUROMODULATION SYSTEMS, INC
Product Code: LGW
PMA / PMN Number: P010032
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TN, 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. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. ANS HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. ANS DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

Description of Event or Problem · 1

DEVICE 1 OF 2: SEE MANUFACTURER'S REPORT NUMBER 1627487-2010-00187 FOR DEVICE 2. A PATIENT WAS IMPLANTED WITH AN SCS SYSTEM TO TREAT HEADACHES. IT WAS REPORTED THAT ON (B) (6) 2009, THE PATIENT'S LEADS WERE REPLACED DUE TO INVALID IMPEDANCE AND LACK OF STIMULATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	QUATTRODE 4 PERCUTANEOUS LEAD	SPINAL CORD STIMULATION LEAD	LGW	ADVANCED NEUROMODULATION SYSTEMS, INC	3166	2796190

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other