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

Model Number PM3210

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Unspecified Infection (1930)

Event Date 10/02/2017

Event Type  Injury  

Event Description

It was reported that the patient had developed a pocket infection.While attempting to use the pulse generator for an external pacer temporarily and upon interrogation the device revealed it was at elective replacement indicator since (b)(6) 2013 before pre-implant.The system was explanted and replaced.The patient's condition before, during and post procedure was stable.

Manufacturer Narrative

The reported event of eri/eos anomaly was not confirmed in the laboratory.The device was tested and the results indicated the device exhibited normal characteristics.

• 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: 7140808
• MDR Text Key: 95581358
• Report Number: 2017865-2017-34444
• 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: 01/16/2018

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: 04/30/2015
• Device Model Number: PM3210
• Device Lot Number: 4304363
• Other Device ID Number: 05414734503785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2017
• Initial Date FDA Received: 12/21/2017
• Supplement Dates Manufacturer Received: 01/09/2018
• Supplement Dates FDA Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2013
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR