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

Model Number PM2112

Device Problem No Device Output (1435)

Patient Problems Cardiac Arrest (1762); Fainting (1847)

Event Date 07/08/2014

Event Type  Injury  

Event Description

It was reported that while receiving external electrical therapy for unrelated symptom, the patient fainted.The pulse generator exhibited loss of output.The patient was asystolic.The patient received external cardioversion.Following external therapies, normal device functions resumed.The device was explanted and replaced on (b)(6) 2014.

Manufacturer Narrative

All information provided by manufacturer, no medwatch form was received.Final analysis found normal pulse generator characteristics.

• Brand Name: ACCENT 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: 4073809
• MDR Text Key: 18539464
• Report Number: 2017865-2014-16796
• Device Sequence Number: 1
• Product Code: DXY
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: Physician
• 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: 02/28/2015
• Device Model Number: PM2112
• Device Catalogue Number: SMTFY999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/15/2013
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Weight: 75