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

Model Number PM3210

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438)

Patient Problem Dizziness (2194)

Event Date 02/15/2020

Event Type  Injury  

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 Description

Related manufacturer reference number: 2017865-2020-02844.It was reported that the patient presented in clinic for routine follow-up experiencing dizziness.Upon interrogation, the pacemaker and right ventricular lead exhibited oversensing of noise.Far-r wave oversensing was also noted.No device intervention was performed.Patient condition was stable.

Manufacturer Narrative

The reported field event of over-sensing was not confirmed in the laboratory.The device was tested on the bench and using automated testing equipment, and no anomalies were found.

Event Description

Additional information received indicated that the patients' right ventricular (rv) lead was capped and replaced on (b)(6) 2021.The patient's pacemaker was also explanted and replaced.The patient was stable throughout.

• 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: 9848973
• MDR Text Key: 183939356
• Report Number: 2017865-2020-02845
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2014
• Device Model Number: PM3210
• Device Catalogue Number: PM3210
• Device Lot Number: 4053212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/27/2020
• Initial Date FDA Received: 03/18/2020
• Supplement Dates Manufacturer Received: 06/23/2021; 07/23/2021
• Supplement Dates FDA Received: 07/07/2021; 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ISOFLEX; ISOFLEX
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 68