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

Model Number	PM3210
Medical Device Problem Codes	Premature Discharge of Battery (1057); Charging Problem (2892)
Health Effect - Clinical Code	Dizziness (2194)
Date of Event	09/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.
Event or Problem Description
It was reported that the patient presented for remote follow up via merlin.Net with the pulse generator exhibiting excessive battery depletion and high current drain.It was noted that the device had stable outputs, pacing lead impedance trends, and there were no changes in pacing percentage.The patient complained of intermittent dizziness and physician decided to explant and replace the device.The patient was discharged in stable condition.
Additional Manufacturer Narrative
The reported event of premature battery depletion issue was not confirmed.Analysis of device image indicates that auto-capture feature was enabled and device was pacing in high output mode at times.When automatic settings are programmed, such as auto-capture feature, the device would adjust itself to accommodate the patient¿s needs for pacing and thus affects the estimated longevity of device.Analysis of device was performed, did not find any anomalies other than voltage being at eri.Longevity assessment was performed and device¿s implanted duration exceeded projected longevity and is considered normal battery depletion.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 10643901
• Report Number: 2017865-2020-14989
• Device Sequence Number: 2438860
• Product Code: NKE
• UDI-Device Identifier: 05414734503785
• UDI-Public: 05414734503785
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P030035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/13/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2015
• Device Model Number: PM3210
• Device Catalogue Number: PM3210
• Device Lot Number: 4456618
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/18/2020
• Supplement Date Received by Manufacturer: 11/18/2020; 01/13/2022
• Initial Report FDA Received Date: 10/07/2020
• Supplement Report FDA Received Date: 11/20/2020; 01/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2014
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 115 KG