FDA Adverse Event Injury Summary report: N

OCTRODE PERCUTANEOUS LEAD

MDR report key: 1924434 · Received December 7, 2010

Report

Report Number: 1627487-2010-03452
Event Type: Injury
Date Received: December 7, 2010
Date of Event: November 29, 2010
Report Date: December 1, 2010
Manufacturer: ST JUDE MEDICAL - NEUROMODULATION DIVISION
Product Code: LGW
PMA / PMN Number: P010032
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

EVALUATION METHOD: 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. SJM HAS LIMITED INFO 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. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

Description of Event or Problem · 1

DEVICE 2 OF 2. REFERENCE MFR. REPORT # 1627487-2010-03451. THE PT WAS IMPLANTED WITH TWO PERCUTANEOUS LEADS ON (B)(6) 2010. IT WAS PREVIOUSLY REPORTED ON (B)(6) 2010, THAT THE PT WAS WITHOUT STIMULATION DIAGNOSTIC TESTS REVEALED INVALID IMPEDANCE READINGS FOR SEVERAL LEAD CONTACTS; HOWEVER, EFFECTIVE THERAPY WAS RECAPTURED THROUGH REPROGRAMMING. FOLLOW-UP ON THE PT FOUND THAT HER LEAD WAS EXPLANTED ON (B)(6) 2010 DUE TO A FRACTURE. IT IS UNK FROM WHICH LOT THE BROKEN LEAD ORIGINATED; THEREFORE, BOTH LOTS ARE BEING REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OCTRODE PERCUTANEOUS LEAD	SPINAL CORD STIMULATION LEAD	LGW	ST JUDE MEDICAL - NEUROMODULATION DIVISION	3186	2870899

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention