FDA Adverse Event Injury Summary report: N

LAMITRODE 88 LEAD KIT, 60CM LENGTH

MDR report key: 1961023 · Received January 11, 2011

Report

Report Number: 1627487-2011-00050
Event Type: Injury
Date Received: January 11, 2011
Date of Event: November 23, 2010
Report Date: December 14, 2010
Manufacturer: ST JUDE MEDICAL - NEUROMODULATION DIVISION
Product Code: LGW
PMA / PMN Number: P010032
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: AZ, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

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 INFORMATION 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 3. REFERENCE MFR REPORT #S 1627487-2011-00049 AND 1627487-2011-00051. THE PATIENT RECEIVED HER SCS SYSTEM ON (B)(6) 2010, CONSISTING OF AN IPG, SURGICAL LEAD AND TWO ANCHORS. IT WAS REPORTED THAT THE PATIENT DEVELOPED AN MRSA INFECTION AT THE IPG POCKET AND LEAD INCISION SITE. HER SCS SYSTEM WAS REMOVED AS A RESULT. INTRAVENOUS ANTIBIOTICS WERE ADMINISTERED AS TREATMENT FOR THE INFECTION. FOLLOW-UP ON THE PATIENT FOUND THAT SHE IS RECOVERING WELL. THE EXPLANTED DEVICES WILL NOT BE RETURNED TO THE MANUFACTURER.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	LAMITRODE 88 LEAD KIT, 60CM LENGTH	SPINAL CORD STIMULATION LEAD	LGW	ST JUDE MEDICAL - NEUROMODULATION DIVISION	3288	3170808

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention