FDA Adverse Event Injury Summary report: N

SINGLE 8 EXTENSION

MDR report key: 1800715 · Received August 12, 2010

Report

Report Number: 1627487-2010-02416
Event Type: Injury
Date Received: August 12, 2010
Date of Event: June 25, 2010
Report Date: June 30, 2010
Manufacturer: ADVANCED NEUROMODULATION SYSTEMS, INC.
Product Code: LGW
PMA / PMN Number: P010032
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

THE DEVICE HISTORY AND STERILIZATION RECORDS WERE 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. COMPLAINT OF INEFFECTIVE STIMULATION WAS CONFIRMED; AS RECEIVED THE 3214 LEAD HAS THREE CHANNELS THAT MEASURE OPEN. IPG AND LEAD EXTENSION PASSED FUNCTIONAL TESTS. 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 4 OF 4. (SEE MFR# 1627487-2010-01493, 1627487-2010-02414, AND 1627487-2010-02415 FOR DEVICES 1, 2, AND 3). ON (B)(6) 2010, THE PT WAS IMPLANTED WITH AN SCS SYSTEM. IT WAS REPORTED THAT THE PT WAS NOT RECEIVING EFFECTIVE STIMULATION, SO ON (B)(6) 2010, THE DOCTOR REVISED THE LEAD. AFTER THE REVISION THE PT STILL WAS NOT RECEIVING EFFECTIVE STIMULATION AND REPORTED EXPERIENCING DIZZINESS, BLURRED VISION, AND HEADACHES WHENEVER THE STIMULATOR WAS TURNED ON. THE SYSTEM WAS EXPLANTED ON (B)(6) 2010.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SINGLE 8 EXTENSION	SPINAL CORD STIMULATION LEAD EXTENSION	LGW	ADVANCED NEUROMODULATION SYSTEMS, INC.	3382	2819747

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other