MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC., CRMD SUSTAIN XL DR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM2136

Device Problem No Device Output (1435)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/23/2013

Event Type  malfunction  

Event Description

It was reported that during the implant procedure the pulse generator exhibited no ventricular capture.The device was not used.

Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received.Analysis found normal device characteristics.

• Brand Name: SUSTAIN XL DR
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC., CRMD; 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: cary lawler ; 15900 valley view court; sylmar, CA 91342 ; 8184932621
• MDR Report Key: 3559793
• MDR Text Key: 16550383
• Report Number: 2017865-2014-00961
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2014
• Device Model Number: PM2136
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2013
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/23/2013
• Device Age: 4 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/24/2013
• Initial Date FDA Received: 01/07/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/20/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1