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); Device Operates Differently Than Expected (2913)

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

Event Date 07/12/2017

Event Type  Injury  

Event Description

It was reported that an asymptomatic patient presented via remote transmission.Review of the transmission revealed noise reversion and several inappropriate auto mode switch episodes due to noise.The patient presented in clinic on (b)(6) 2017.The noise was reproducible on isometrics.Lead issue was suspected.Generator and lead replacement was discussed.No intervention was performed.The patient will continue to be monitored via remote transmission.

Event Description

New information states that the device was explanted and replaced on (b)(6) 2018.The patient was in a stable condition before, during and after the procedure.

• 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: 6985807
• MDR Text Key: 90782543
• Report Number: 2017865-2017-33798
• 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: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2017
• 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: 2870462
• Other Device ID Number: 05414734503785
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2009
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR