DURATA STS OPTIM ACTIVE FIXATION

MDR report key: 1895957 · Received November 10, 2010

Report

Report Number: 2017865-2010-04617
Event Type: Injury
Date Received: November 10, 2010
Date of Event: September 14, 2010
Manufacturer: ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION
Product Code: LWS
PMA / PMN Number: P950022
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

Additional Manufacturer Narrative · 1

THE DAMAGE FOUND WAS SUSTAINED DURING THE SURGICAL PROCEDURE.

Description of Event or Problem · 1

THE PATIENT PRESENTED TO THE ER ON (B)(6) 2010, WITH COMPLAINT OF PALPITATIONS AND SHORTNESS OF BREATH. IT WAS REPORTED THAT THE PATIENT HAD TWIDDLER'S SYNDROME. IT WAS NOTED THAT THE THRESHOLDS AND RV SENSING HAD CHANGED. A CHEST X-RAY REVEALED THAT BOTH LEADS WERE DISLODGED. BOTH LEADS WERE REPLACED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PHYSICIAN TRAINED IN THE USE OF THE PROGLIDE DEVICE ATTEMPTED ARTERIOTOMY CLOSURE OF A FEMORAL ARTERY AFTER AN UNSPECIFIED PROCEDURE. REPORTEDLY, WHEN THE NEEDLE PLUNGER WAS REMOVED, A CUFF MISS OCCURRED. THE DEVICE WAS REMOVED AND THE METHOD THAT HEMOSTASIS WAS ACHIEVED WAS NOT REPORTED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	DURATA STS OPTIM ACTIVE FIXATION	DEFIBRILLATION LEAD	LWS	ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION	7122/65

Patients

Seq	Age	Sex	Outcome	Treatment
1	57 YR		Required Intervention	(B)(4)