MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) UNIFY CRT-D; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3235-40Q

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 03/19/2015

Event Type  Injury  

Manufacturer Narrative

The initial medical device report was submitted 2938836-2015-03871.Lithium clusters were observed during the analysis.No additional analysis is necessary.

Event Description

It was reported that the device reached eos and customer felt that the device may have changed the permanent settings of the vt1 zone therapy.The device was explanted for routine eos.Patient was discharged following device change out.

• Brand Name: UNIFY CRT-D
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 7379555
• MDR Text Key: 103771875
• Report Number: 2938836-2018-02792
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 01/31/2012
• Device Model Number: CD3235-40Q
• Device Catalogue Number: CD3235-40Q
• Device Lot Number: 3168596
• Other Device ID Number: 05414734503563
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2018
• Initial Date FDA Received: 03/28/2018
• Date Device Manufactured: 07/08/2010
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Removal/Correction Number: Z-0116-2017
• Patient Sequence Number: 1