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

Model Number PM3210

Device Problems Low impedance (2285); Capturing Problem (2891); Appropriate Term/Code Not Available (3191); High Capture Threshold (3266)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/22/2020

Event Type  malfunction  

Manufacturer Narrative

The pacemaker cap confirm was automatically disabled with no abnormal right ventricular lead impedance.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

It was reported that the patient presented to the clinic for routine pacemaker check.Upon interrogation of the device, it was discovered that a polarity switch occurred on the left ventricular lead and the cap confirm setting was automatically disabled on the left and right ventricular leads.It was noted that the left ventricular lead exhibited low lead impedance causing the polarity switch.The right ventricular lead, however, did not exhibit any abnormal lead impedance.The pacemaker output also increased for both lead chambers.The leads were manually tested and found to have stable impedance and threshold.It was noted that the patient underwent some radiation therapy during the time of the event.The device and lead were then reprogrammed back to the appropriate settings.There were no adverse consequences to the patient.Related manufacturer reference number: 2017865-2020-01823.

• 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
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 9690860
• MDR Text Key: 178574414
• Report Number: 2017865-2020-01822
• Device Sequence Number: 1
• Product Code: NKE
• UDI-Device Identifier: 05414734503785
• UDI-Public: 05414734503785
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2015
• Device Model Number: PM3210
• Device Catalogue Number: PM3210
• Device Lot Number: 4397522
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/22/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: QUICKSITE
• Patient Age: 74 YR