MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. UNIFY QUADRA CRT-D, OUS MODEL, DF4COMP; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3251-40Q

Device Problems Device Alarm System (1012); Vibration (1674)

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

Event Type  Injury  

Manufacturer Narrative

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 a follow-up, the vibratory alert could not be felt by the patient or the physician.The device was explanted and replaced.The patient was stable with no adverse consequences.

Manufacturer Narrative

Additional information: the reported event of patient notifier anomaly could not be confirmed.The device¿s sensing, pacing, lead impedance, high voltage charging, high voltage delivery and high voltage shock impedance were tested, and the device¿s function was normal.The patient notifier was tested, and it activated normally.Based on the analysis and information received from the field, the cause of the reported incident remains undetermined.

• Brand Name: UNIFY QUADRA CRT-D, OUS MODEL, DF4COMP
• 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: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8331428
• MDR Text Key: 135881660
• Report Number: 2938836-2019-01031
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2013
• Device Model Number: CD3251-40Q
• Device Catalogue Number: CD3251-40Q
• Device Lot Number: 3750191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2012
• 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): Hospitalization; Required Intervention