FDA Adverse Event Malfunction Summary report: N

SINGLE 8 EXTENSION

MDR report key: 1883153 · Received October 19, 2010

Report

Report Number: 1627487-2010-02862
Event Type: Malfunction
Date Received: October 19, 2010
Date of Event: September 22, 2010
Report Date: September 22, 2010
Manufacturer: ADVANCED NEUROMODULATION SYSTEMS, INC.
Product Code: GZB
PMA / PMN Number: P010032
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

EVAL: METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE ALSO REVIEWED. RESULTS: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED AND 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 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

ON (B)(6) 2010, THE PT WAS IMPLANTED WITH A TRIAL SCS SYS. WHEN THE PT CAME IN TO HAVE THE EXTENSION REMOVED, THE DOCTOR CUT THE HEADER OFF THE EXTENSION AND THE NURSE THEN PULLED FROM THE END OF THE EXTENSION THAT WAS CONNECTED TO THE TRIAL STIMULATOR TO REMOVE THE BODY OF THE DEVICE. WHEN THE EXTENSION WAS PULLED OUT, HALF OF THE LEAD BODY HAD EXPOSED WIRES. IT IS BELIEVED THAT THE SHEATH FOR THE EXPOSED HALF OF THE BODY IS STILL IN THE PT. THE DOCTOR PROCEEDED WITH IMPLANTING THE PERMANENT SYS IN THE PT. THE IPG WAS IMPLANTED AND CONNECTED TO THE EXISTING LEAD.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SINGLE 8 EXTENSION	SPINAL CORD STIMULATION LEAD	GZB	ADVANCED NEUROMODULATION SYSTEMS, INC.	3383	3136782

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other