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	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the battery longevity estimate was 2 years in dec, 2020, 11.7 months in june, 2021 and less than 3 months to the elective replacement indicator (eri) in sep, 2021.The device had been implanted for 8 years.No anomalies were noted throughout the life of the device but there was a concern of battery overestimation of longevity.The device was to be explanted once eri was reached.The patient was stable before, during and after the event.
Event or Problem Description
New information received notes the device was explanted after reaching the elective replacement indicator (eri).
Additional Manufacturer Narrative
The reported event of incorrect measurement was not confirmed.Device image indicated that autocapture feature was enabled and field data shows device operated in rate responsive mode.When automatic settings are programmed, such as autocapture and rate responsive mode, the device output would adjust itself to accommodate the patient¿s needs for pacing and thus affect the estimated longevity of the device.Analysis performed in nominal settings, including testing at various pulse amplitudes, did not find any anomalies.The device was implanted for 8.54 years which exceeded the device¿s 7.91 year projected longevity and is considered normal battery depletion.
Event or Problem Description
New information notes the patient was stable before during and after the explant procedure for the elective replacement indicator.

• 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: 12565194
• Report Number: 2017865-2021-31874
• Device Sequence Number: 20771631
• Product Code: NKE
• UDI-Device Identifier: 05414734503785
• UDI-Public: 05414734503785
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P030035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2014
• Device Model Number: PM3210
• Device Catalogue Number: PM3210
• Device Lot Number: 3991600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2021
• Supplement Date Received by Manufacturer: 01/06/2022; 03/28/2022; 03/30/2022
• Initial Report FDA Received Date: 10/01/2021
• Supplement Report FDA Received Date: 01/24/2022; 03/29/2022; 04/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/14/2013
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TENDRIL LEAD; TENDRIL LEAD
• Patient Age: 75 YR
• Patient Sex: Female