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

Model Number PM3210

Device Problems Failure to Capture (1081); Over-Sensing (1438); Failure to Sense (1559)

Patient Problem Dyspnea (1816)

Event Date 01/15/2018

Event Type  Injury  

Event Description

It was reported that the patient presented in clinic after experiencing heart failure symptoms and shortness of breath.It was noted that the right atrial and right ventricle were not capturing.The patient was in atrial fibrillation, the pulse generator did not show any atrial activity, and rather it mirrored the ventricular activity.X-ray imaging of the leads showed normal placement.The physician suspected the issues to be device related.The device was explanted and replaced.During the procedure, it was noted that the threshold on the right ventricular lead was high.The lead was capped and replaced on (b)(6) 2018.The patient was stable before, during and after the procedure.

Manufacturer Narrative

Device was tested on the bench and 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
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7252914
• MDR Text Key: 99384870
• Report Number: 2017865-2018-02275
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P880086
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/22/2018

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: 04/30/2011
• Device Model Number: PM3210
• Device Lot Number: 2864284
• Other Device ID Number: 05414734503785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2018
• Initial Date FDA Received: 02/08/2018
• Supplement Dates Manufacturer Received: 04/09/2018
• Supplement Dates FDA Received: 04/22/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2009
• 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: 1688TC/58, (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 81 YR