FDA Adverse Event Injury Summary report: N

SECURA VR

MDR report key: 1991895 · Received February 15, 2011

Report

Report Number: 6000144-2011-00959
Event Type: Injury
Date Received: February 15, 2011
Manufacturer: MEDTRONIC MED REL, INC.
Product Code: LWS
PMA / PMN Number: P980016/S114
Removal / Correction Number: ASKU
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KY, US
Reporter Occupation: RISK MANAGER

Narratives

Additional Manufacturer Narrative · 1

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED FOR ANALYSIS. THE ANALYSIS REVEALED NO ANOMALIES FOUND. ANALYSIS OF THE LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

Additional Manufacturer Narrative · 1

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED FOR ANALYSIS. THE ANALYSIS REVEALED NO ANOMALIES FOUND. (B)(4) THE FULL LEAD WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND. IT WAS NOTED THAT THERE WAS BLOOD/BODY FLUID ON THE DISTAL CONDUCTOR (NOT OBSTRUCTED), THE OUTER TUBING OVERLAY HAD COSMETIC ENVIRONMENTAL STRESS CRACKING, THERE WAS BLOOD IN/ON THE HELIX MECHANISM (SLEEVE HEAD) AND THERE WAS BLOOD IN/ON THE HELIX MECHANISM.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE DEVICE AND LEAD WERE REMOVED FOLLOWING THE DEVELOPMENT OF SEPSIS AND AN INFECTION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SECURA VR	IMPLANTABLE PACEMAKER/CARDIO/DEFIB	LWS	MEDTRONIC MED REL, INC.	D224VRC	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1	53 YR		Hospitalization\| R