MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) ACCENT SR; IMPLANTABLE PACEMAKER PULSE GENERATOR

Model Number PM1110

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiomyopathy (1764); Death (1802); Myocardial Infarction (1969); Ventricular Fibrillation (2130)

Event Date 11/12/2016

Event Type  Death  

Manufacturer Narrative

Analysis was normal.No anomalies were found.

Event Description

It was reported that the patient expired.There is no known allegation from a health professional that suggests the death was related to the device.It was reported that the cause of death is myocardial infarction, ventricular fibrillation and congestive cardiomyopathy.

• Brand Name: ACCENT SR
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7529667
• MDR Text Key: 108754082
• Report Number: 2938836-2018-07364
• Device Sequence Number: 1
• Product Code: LWP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2013
• Device Model Number: PM1110
• Device Lot Number: 3743013
• Other Device ID Number: 05414734502740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/30/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2012
• 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
• Treatment: 1688TC/58, DP167776
• Patient Outcome(s): Death
• Patient Age: 87 YR