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

Model Number PM1240

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

Patient Problems Death (1802); Insufficient Information (4580)

Event Date 10/30/2020

Event Type  Death  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

Relevant manufacturer report number: 2017865-2020-19388.It was reported that the patient has deceased.There is no known allegation from a health care professional that suggests that the death was device related.The causes of death were renal failure, pericardial effusion, failure to thrive, and dementia.No additional information was reported.

Manufacturer Narrative

Final analysis showed the reported event of unknown patient death was not confirmed and not attributed to the pacemaker device.The pacemaker exhibited normal device characteristics.

• Brand Name: ASSURITY SR RF
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10980784
• MDR Text Key: 220583877
• Report Number: 2017865-2020-19387
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734507066
• UDI-Public: 05414734507066
• Combination Product (y/n): N
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2016
• Device Model Number: PM1240
• Device Catalogue Number: PM1240
• Device Lot Number: 4734430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 12/09/2020
• Supplement Dates Manufacturer Received: 01/11/2021
• Supplement Dates FDA Received: 02/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TENDRIL STS; TENDRIL STS
• Patient Outcome(s): Death
• Patient Age: 80 YR