FDA Adverse Event Injury Summary report: N

CINCH ANCHOR

MDR report key: 1962771 · Received January 13, 2011

Report

Report Number: 1627487-2011-01048
Event Type: Injury
Date Received: January 13, 2011
Date of Event: December 16, 2010
Report Date: December 16, 2010
Manufacturer: ST JUDE MEDICAL - NEUROMODULATION DIV.
Product Code: LGW
PMA / PMN Number: K081208
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: GA, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

EVALUATION: 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 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 3 OF 3. REFERENCE MANUFACTURER REPORTS: 1627487-2011-01046 AND 1627487-2011-01047. THE PT RECEIVED HER SCS SYSTEM, INCLUDING AN IPG, A SURGICAL LEAD, AND ANCHOR, ON (B)(6) 2010. IT WAS REPORTED THAT THE PT DEVELOPED HIVES ALL OVER HER BODY AFTER THE IMPLANT DATE. THE PT WAS REFERRED TO A DERMATOLOGIST AND SHE BEGAN STEROID THERAPY FOR THE ALLERGIC RESPONSE. FOLLOW UP ON THE PT FOUND THAT THE PHYSICIAN WILL PERFORM ALLERGY TESTING ONCE THE PT HAS FINISHED STEROID THERAPY. THE SCS SYSTEM REMAINS IMPLANTED IN THE PT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	CINCH ANCHOR	SPINAL CORD STIMULATION ANCHOR	LGW	ST JUDE MEDICAL - NEUROMODULATION DIV.	1194	3143591

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention