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

Model Number	PM3210
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Arrhythmia (1721)
Date of Event	07/10/2021
Type of Reportable Event	Death
Event or Problem Description
Related manufacturer reference number: 2017865-2021-28993.Related manufacturer reference number: 2017865-2021-28994.It was reported that the patient has deceased.There is no known allegation from a health care professional that suggests the death was device related.The cause of death was cardiac arrest.No additional information was reported.
Additional Manufacturer Narrative
The device was received from the field with battery voltage above elective replacement indicator (eri) level.Analysis of device image and longevity assessment testing indicated that the device was within normal range of operation.

• Brand Name: ANTHEM RF CRT-P
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 12368109
• Report Number: 2017865-2021-28989
• Device Sequence Number: 14536272
• Product Code: NKE
• UDI-Device Identifier: 05414734503785
• UDI-Public: 05414734503785
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P030035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2013
• Device Model Number: PM3210
• Device Catalogue Number: PM3210
• Device Lot Number: 3653154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 08/05/2021
• Supplement Date Received by Manufacturer: 09/15/2021
• Initial Report FDA Received Date: 08/25/2021
• Supplement Report FDA Received Date: 10/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TENDRIL STS; TENDRIL STS; TENDRIL STS; TENDRIL STS
• Outcome Attributed to Adverse Event: Death