FDA Adverse Event Injury Summary report: N

OCTRODE

MDR report key: 2850119 · Received November 27, 2012

Report

Report Number: 1627487-2012-11724
Event Type: Injury
Date Received: November 27, 2012
Date of Event: November 1, 2012
Report Date: November 2, 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. RESULT - REVIEW OF THE DHR FOUND A NONCONFORMANCE RELATED TO THE PRODUCT LOT. HOWEVER, THE INDIVIDUAL AFFECTED DEVICE WAS REWORKED AND ALL DEVICES WITHIN THE LOT MET ACCEPTANCE CRITERIA. THEREFORE, 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 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. REF MFR REPORT: 1627487-2012-11723. THE PT RECEIVED TWO ANCHORS WITH THE SAME LOT NUMBER, AND TWO LEADS WITH THE SAME LOT NUMBER. IT WAS REPORTED THE PT HAD AN INFECTION AT THE ANCHOR SITE. IT WAS REPORTED A CULTURE HAD BEEN TAKEN, BUT THE INFECTION TYPE WAS NOT DETERMINED. THE PT WAS PLACED ON ORAL ANTIBIOTICS, AND THE SCS SYSTEM WAS EXPLANTED. F/U IDENTIFIED THE INFECTION HAD HEALED POSTOPERATIVE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	OCTRODE	SCS LEAD	LGW	ST JUDE MEDICAL - NEUROMODULATION	3186	3376646

Patients

Seq	Age	Sex	Outcome	Treatment
1	60 YR		Required Intervention	IMPLANT DATE:\| SCS IPG: MODEL 3788