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

Model Number PM3210

Device Problems Premature Discharge of Battery (1057); Failure to Capture (1081)

Patient Problems Arrhythmia (1721); Discomfort (2330)

Event Date 05/03/2021

Event Type  Injury  

Event Description

It was reported that the patient presented in the emergency room experiencing chest pain and arrhythmia, the patient's heart rate was at 40 beats per minute.Upon review, the pacemaker exhibited voltage less than that of the device's end of life showing premature battery depletion and as a result failed to capture the heart.The pacemaker was explanted and replaced.Patient was stable.

Manufacturer Narrative

Analysis was normal.No anomalies were found.

• Brand Name: ANTHEM RF CRT-P
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 11871454
• MDR Text Key: 252215587
• Report Number: 2017865-2021-18897
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 05414734503785
• UDI-Public: 05414734503785
• Combination Product (y/n): N
• PMA/PMN Number: P030035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2015
• Device Model Number: PM3210
• Device Catalogue Number: PM3210
• Device Lot Number: 4347284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR
• Patient Weight: 100