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

Model Number PM3212

Device Problem Improper Device Output (2953)

Patient Problems Ventricular Fibrillation (2130); Ventricular Tachycardia (2132)

Event Date 02/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that while hospitalized due to a non-device related issue, the patient developed episodes of ventricular tachycardia, ventricular fibrillation.These episodes were observed on stored electrograms after pulse generator interrogation.For some of the episodes the patient was cardioverted externally.It was noted that all episodes started at the same hourly timestamp.On (b)(6) 2016 cap confirm was turned off and no new episodes of vt/vf were seen after reprogramming.There were no further consequences for the patient.

• Brand Name: ANTHEM RF CRT-P
• Type of Device: IMPLANTABLE PACEMAKER PULSE GENERATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC. (CRM-KISTA); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC. (CRM-KISTA); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: jaime chavez ; 15900 valley view court; sylmar, CA 91342 ; 8184934022
• MDR Report Key: 5526006
• MDR Text Key: 41372702
• Report Number: 3010215456-2016-01961
• Device Sequence Number: 1
• Product Code: NKE
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2011
• Device Model Number: PM3212
• Device Lot Number: 3106995
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2010
• 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 Age: 63 YR