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

Model Number	PM3210
Medical Device Problem Codes	Failure to Interrogate (1332); Wireless Communication Problem (3283)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Insufficient Information (4580)
Date of Event	06/17/2020
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 patient¿s device was not able to be interrogated.The interrogation was attempted using inductive telemetry, different programmer, clearing the environment to remove effect of electromagnetic interference (emi), magnet, radio frequency telemetry test.All troubleshooting failed.The decision was made to interrogate the device in a different room.If interrogation fails, the device replacement was discussed.Further information was requested but was not received.
Event or Problem Description
New information received notes that the device was explanted and replaced.Elective replacement indicator (eri) was also noted.
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Additional Manufacturer Narrative
The reported field event of failure to interrogate was not confirmed in the laboratory.The device was tested on the bench, and no anomalies were found.

• Brand Name: ANTHEM RF CRT-P
• Common Device Name: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 10211387
• Report Number: 2938836-2020-07174
• Device Sequence Number: 2120841
• Product Code: NKE
• UDI-Device Identifier: 05414734503785
• UDI-Public: 05414734503785
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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: 2020
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2014
• Device Model Number: PM3210
• Device Catalogue Number: PM3210
• Device Lot Number: 3782427
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/17/2020
• Supplement Date Received by Manufacturer: 11/12/2020; 02/18/2021
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 12/05/2020; 02/25/2021
• 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