VICTORY XL DR 5816 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2009-06-02 for VICTORY XL DR 5816 * manufactured by St. Jude Medical, Cardiac Rhythm.

Event Text Entries

[1162791] During routine pacemaker implantation the operating physician began to connect the newly implanted pacing leads to the new pacemaker. It was noted at that time that the mechanism (set screw) which holds the atrial lead in place on the device header block was not working smoothly. When the physician tried to release the lead from the device head block, the screw tool was able to rotate freely without disengaging the set screw. It was thought at the time that the issue may be the wrench itself which had been recently remodeled by the manufacturer. An older style wrench was issued to the sterile table and the set screw was loosened when it subsequently disengaged completely from the header. Another pacemaker was dropped to the table at this time and was attached to the implanted leads without incident. Diagnostic testing was performed and no damage or malfunction of the lead in question was noticed. There was no harm to the patient. The pacemaker in question is a st. Jude medical model: victory xl dr (5816) and the 2 wrenches come together in an accessory kit. ====================== manufacturer response for pacemaker, victory xl dr======================manufacturer has requested and the facility will release the device to the manufacturer.
Patient Sequence No: 1, Text Type: D, B5

[1272363] During routine pacemaker implantation the operating physician began to connect the newly implanted pacing leads to the new pacemaker. It was noted at that time that the mechanism (set screw) which holds the atrial lead in place on the device header block was not working smoothly. When the physician tried to release the lead from the device head block, the screw tool was able to rotate freely without disengaging the set screw. It was thought at the time that the issue may be the wrench itself which had been recently remodeled by the manufacturer. An older style wrench was issued to the sterile table and the set screw was loosened when it subsequently disengaged completely from the header. Another pacemaker was dropped to the table at this time and was attached to the implanted leads without incident. Diagnostic testing was performed and no damage or malfunction of the lead in question was noticed. There was no harm to the patient. The pacemaker in question is a st. Jude medical model: victory xl dr (5816) and the 2 wrenches come together in an accessory kit. ====================== manufacturer response for pacemaker, victory xl dr======================manufacturer has requested and the facility will release the device to the manufacturer.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1404097
• MDR Report Key: 1404097
• Date Received: 2009-06-02
• Date of Report: 2009-06-02
• Date of Event: 2009-05-22
• Report Date: 2009-06-02
• Date Reported to FDA: 2009-06-02
• Date Added to Maude: 2009-06-19
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: VICTORY XL DR
• Generic Name: PACEMAKER, IMPLANTABLE
• Product Code: DXY
• Date Received: 2009-06-02
• Model Number: 5816
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: R
• Device Age: 1 DY
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: ST. JUDE MEDICAL, CARDIAC RHYTHM
• Manufacturer Address: DIRECTOR, REGULATORY COMPLIANC 15900 VALLEY VIEW CT SYLMAR CA 91342 US 91342

Device Sequence Number: 2

• Brand Name: HEX WRENCH
• Generic Name: TOOLS, PACEMAKER
• Product Code: DTF
• Date Received: 2009-06-02
• Model Number: 442-2
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: R
• Device Age: 1 DY
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: ST. JUDE MEDICAL
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0		2009-06-02