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

Model Number PM3212

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Ventricular Tachycardia (2132); Loss of consciousness (2418)

Event Date 03/21/2017

Event Type  Injury  

Event Description

It was reported that the patient had ventricular tachycardia that lead to coma.The patient is still unconscious.No further information was reported.

Event Description

New information reported stated that the physician did not suspect that the device or leads contributed to the patient's condition.The patient remained unconscious but remained under "continuous improvement".No additional information was reported.

• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6522466
• MDR Text Key: 73726179
• Report Number: 2017865-2017-02605
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/17/2017

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2018
• Device Model Number: PM3212
• Device Lot Number: S000023717
• Other Device ID Number: 05414734502788
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/21/2017
• Initial Date FDA Received: 04/26/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/17/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2016
• 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: (B)(4)