FDA Adverse Event Injury Summary report: N

LAMITRODE S-8, 30CM LENGTH

MDR report key: 2153358 · Received June 30, 2011

Report

Report Number: 1627487-2011-00901
Event Type: Injury
Date Received: June 30, 2011
Date of Event: June 1, 2011
Report Date: June 1, 2011
Manufacturer: ST. JUDE MEDICAL - NEUROMODULATION
Product Code: LGW
PMA / PMN Number: P010032
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: BE
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

EVALUATION: METHOD - THE DEVICE HISTORY AND STERILIZATION RECORDS WERE REVIEWED. RESULTS - REVIEW OF THE DEVICE HISTORY RECORD FOUND A NONCONFORMANCE; HOWEVER, THE NONCONFORMANCE WAS IDENTIFIED AS A COSMETIC ISSUE AND DID NOT AFFECT PRODUCT INTEGRITY OR PRODUCT FUNCTIONALITY; THEREFORE, THE DEVICE WAS APPROVED FOR USE. THE DHR ANOMALY IS NOT RELATED TO THE REPORTED EVENT. 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 1 OF 2. REFERENCE MFR. REPORT # 1627487-2011-00902. THE PATIENT (B)(6) RECEIVED AN SCS SYSTEM INCLUDING A SURGICAL LEAD ON (B)(6) 2011. IT WAS REPORTED THAT THE PATIENT DEVELOPED AN INFECTION, AND HER LEAD AND EXTENSION WERE EXPLANTED. THE EXPLANTED DEVICES WILL NOT BE RETURNED TO THE MANUFACTURER. NO FURTHER INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	LAMITRODE S-8, 30CM LENGTH	SPINAL CORD STIMULATION LEAD	LGW	ST. JUDE MEDICAL - NEUROMODULATION	3283	3166292

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention	SCS IPG: MODEL UNKNOWN\| IMPLANTED: