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	Failure to Interrogate (1332); Interrogation Problem (4017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information was requested but not received.
Event or Problem Description
It was reported the pacemaker exhibited a radio frequency (rf) telemetry anomaly.The pacemaker was explanted and replaced.The patient condition was unknown.No further information was reported on this event.
Event or Problem Description
New information noted the patient initially presented prior to a routine generator exchange.During the device check, the pacemaker could not be interrogated through inductive telemetry.The pacemaker was explanted and replaced.The patient was in stable condition.
Additional Manufacturer Narrative
The reported event of failure to interrogate through radio frequency (rf) telemetry was confirmed.The pacemaker was received at elective replacement indicator (eri) communication through inductive telemetry only.As the device reaches eri, rf telemetry becomes unavailable to save battery.Review of the device image indicates rf telemetry was enabled in the field.Electrical and longevity assessments were normal with no anomalies found.

• 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: richard williamson ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 16997825
• Report Number: 2017865-2023-20965
• Device Sequence Number: 7067220
• Product Code: NKE
• UDI-Device Identifier: 05414734503785
• UDI-Public: 05414734503785
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: 2023
• 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
• Report Date (Section B): 06/14/2023

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: 12/31/2014
• Device Model Number: PM3210
• Device Catalogue Number: PM3210
• Device Lot Number: 4137593
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/03/2023
• Supplement Date Received by Manufacturer: 05/26/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2013
• 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: QUICKFLEX MICRO; TENDRIL STS; TENDRIL STS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male