FDA Adverse Event Injury Summary report: N

OCTRODE 8 PERCUTANEOUS LEAD

MDR report key: 1634698 · Received March 17, 2010

Report

Report Number: 1627487-2010-00170
Event Type: Injury
Date Received: March 17, 2010
Date of Event: February 16, 2010
Report Date: February 22, 2010
Manufacturer: ADVANCED NEUROMODULATION SYSTEMS, INC.
Product Code: LGW
PMA / PMN Number: P010032
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NC, 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 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. SEE MFR'S REPORT NUMBER 1627487-2010-00121 FOR DEVICE 1. ON (B) (6) 2010, THE PT WAS IMPLANTED WITH AN SCS SYSTEM PLACED AT T-12. POST-OP, THE PT COMPLAINED OF SEVERE PAIN IN THE LEFT LEG, EVEN THOUGH THE STIMULATOR WAS OFF. ON (B) (6) 2010, THE PT WAS SENT TO A NEUROSURGEON. THE PT HAD A CT SCAN WHICH REVEALED THAT THE PERCUTANEOUS LEADS WERE PLACED INTRATHECALLY. ON (B) (6) 2010, THE DOCTOR REPAIRED THE DURA BY SUTURING IT CLOSED AND REPLACED THE PERCUTANEOUS LEADS WITH A PADDLE LEAD PLACED AT T8-T9. THE PT IS DOING WELL POST REVISION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OCTRODE 8 PERCUTANEOUS LEAD	SPINAL CORD STIMULATION LEAD	LGW	ADVANCED NEUROMODULATION SYSTEMS, INC.	3186	2881379

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other