MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. PROMOTE ACCEL ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3215-36

Device Problem Programming Issue (3014)

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

Event Date 01/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

During device interrogation, an episode of supraventricular tachycardia (svt) was diagnosed incorrectly.Technical support reviewed the session records which indicated the rhythm was detected as bigeminal.The device was reprogrammed and the event was resolved with no adverse consequences to the patient.

• Brand Name: PROMOTE ACCEL ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 645 almanor avenue; sunnyvale CA 94085
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6296447
• MDR Text Key: 66600160
• Report Number: 2938836-2017-13494
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P030054
• 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
• Report Date: 01/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2012
• Device Model Number: CD3215-36
• Device Lot Number: 3326188
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/15/2011
• 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