FDA Adverse Event Injury Summary report: N

OCTRODE

MDR report key: 3032346 · Received March 29, 2013

Report

Report Number: 1627487-2013-13476
Event Type: Injury
Date Received: March 29, 2013
Date of Event: March 1, 2013
Report Date: March 6, 2013
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

EVALUATION, METHOD: THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS: 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 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 2 OF 3. REFERENCE MFR. REPORT: 1627487-2013-13475 & 1627487-2013-13477. THE PT HAS TWO LEADS FROM DIFFERENT LOT NUMBERS, REPORTING ON BOTH. IT WAS REPORTED THE PT'S SCS SYSTEM WAS EXPLANTED DUE TO AN INFECTION. THE PT'S PHYSICIAN STATED THE PT'S INCISION DID NOT CLOSE PROPERLY AND HE NOTED SOME PUS BUILD UP NEAR THE LEAD (OFF-LABEL) INCISION SITE. FOLLOW-UP INFORMATION IDENTIFIED THE PT WAS TREATED WITH ORAL ANTIBIOTICS AND WAS DOING BETTER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
130670	OCTRODE	SCS LEAD	LGW	ST. JUDE MEDICAL - NEUROMODULATION	3189	3389103

Patients

Seq	Age	Sex	Outcome	Treatment
1	62 YR		Required Intervention