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

Model Number PM2136

Device Problems No Device Output (1435); Connection Problem (2900)

Patient Problems Fall (1848); Collapse (2416)

Event Type  Injury  

Event Description

It was reported that the pulse generator exhibited loss of output.The patient collapsed, resulting in a fall from the ladder.Upon pocket revision, it was observed that the lead had disconnected from the pulse generator.The device was explanted and replaced.The setscrews securing the lead were found to be damaged.

Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received.

• 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: jennie hamel ; 15900 valley view court; sylmar, CA 91342 ; 8184933462
• MDR Report Key: 4073802
• MDR Text Key: 4900248
• Report Number: 2017865-2014-16787
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2014
• Device Model Number: PM2136
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/09/2012
• 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
• Patient Outcome(s): Required Intervention