FDA Adverse Event Injury Summary report: N

ANCHOR

MDR report key: 3010650 · Received March 14, 2013

Report

Report Number: 1627487-2013-02367
Event Type: Injury
Date Received: March 14, 2013
Date of Event: October 18, 2009
Report Date: February 20, 2013
Manufacturer: ST. JUDE MEDICAL - NEUROMODULATION
Product Code: LGW
PMA / PMN Number: K081208
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: THE DEVICE HISTORY AND STERILIZATION RECORDS REVIEWED WERE FOUND TO MEET SPECIFICATIONS AND NO ANOMALIES RELATED TO THIS EVENT 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 3 OF 3. REFERENCE MFR REPORTS: 1627487-2013-02365 AND 02366. THE PATIENT RECEIVED TWO LEADS FROM THE SAME LOT AND TWO ANCHORS FROM THE SAME LOT AS PART OF HIS SCS SYSTEM. IT WAS REPORTED THE PATIENT HAD HIS SYSTEM EXPLANTED APPROXIMATELY (B)(6) 2009 DUE TO A (B)(6) INFECTION. THE PATIENT STATED HE WAS HOSPITALIZED FOR THE INFECTION AND WAS TREATED BY AN INFECTIOUS DISEASE PHYSICIAN FOR APPROXIMATELY 10 MONTHS. HE REPORTED THE INFECTION HAD ENCAPSULATED ON HIS SPINE AND HE WAS TREATED EXTENSIVELY WITH MEDICATION. IT WAS REPORTED AN MRI WAS TAKEN AFTER HIS TREATMENT AND IT SHOWED THE INFECTION HAD CLEARED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
108312	ANCHOR	SCS ANCHOR	LGW	ST. JUDE MEDICAL - NEUROMODULATION	1194	2852699

Patients

Seq	Age	Sex	Outcome	Treatment
1	64 YR		Hospitalization\| R