FDA Adverse Event Injury Summary report: N

OCTRODE

MDR report key: 2820153 · Received November 2, 2012

Report

Report Number: 1627487-2012-02596
Event Type: Injury
Date Received: November 2, 2012
Date of Event: October 8, 2012
Report Date: October 8, 2012
Manufacturer: ST. JUDE MEDICAL - NEUROMODULATION
Product Code: LGW
PMA / PMN Number: P010032
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TX, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: REVIEW OF THE DHR FOUND A NONCONFORMANCE RELATED TO THE PRODUCT. HOWEVER, THE NONCONFORMANCE WAS IDENTIFIED AS A COSMETIC ISSUE, AND THE PRODUCT INTEGRITY AND FUNCTIONALITY MET THE FINAL ACCEPTANCE CRITERIA. THE DHR ANOMALY IS NOT RELATED TO THE ALLEGED DEVICE COMPLAINT. CONCLUSION: THE CAUSE OF THE REPORTED COMPLAINT COULD NOT BE DETERMINED FROM THE REVIEW OF THE DHR AND STERILIZATION RECORDS. SJM 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. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.

Description of Event or Problem · 1

DEVICE 3 OF 4. REFERENCE MFR REPORTS: 1627487-2012-02594, 02595, 02597. IT WAS REPORTED THE PT DEVELOPED INFECTION AT THE ANCHOR SITE. THE PHYSICIAN REMOVED THE PT'S ENTIRE SYSTEM ON (B)(6) 2012. IT WAS REPORTED THE PT WAS TREATED WITH ANTIBIOTICS. FOLLOW-UP IDENTIFIED CULTURE RESULTS SHOWED (B)(6) INFECTION. THE PHYSICIAN REPORTED THE PT IS CURRENTLY IN A PHYSICAL REHABILITATION FACILITY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OCTRODE	SCS LEAD	LGW	ST. JUDE MEDICAL - NEUROMODULATION	3186	3706046

Patients

Seq	Age	Sex	Outcome	Treatment
1	49 YR		Required Intervention	IMPLANT DATE:\| SCS IPG: MODEL 3788