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

Model Number CD3235-40Q

Device Problem Defective Alarm (1014)

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

Event Date 10/17/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that when the patient presented to the hospital for a device check, the vibration alert function was unable to be activated during testing.The programmer was rebooted and the telemetry method was changed from rf to wand, but the issue was not resolved.A software update for the programmer was performed, but the issue still was unable to be resolved.There were no adverse consequences to the patient.Device replacement was planned.

Event Description

New information received indicates that the device was explanted and replaced.There were no adverse consequences to the patient.

Manufacturer Narrative

No conclusion code available; the reported field event of an anomalous vibratory patient notifier was confirmed in the laboratory.The patient notifier was activated using the programmer but the notifier would not vibrate.The device was tested on the bench and no anomalies were found.The cause of the anomalous vibratory notifier could not be determined.

• Brand Name: UNIFY CRT-D
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6099522
• MDR Text Key: 59792807
• Report Number: 2938836-2016-14161
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 10/17/2016

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2014
• Device Model Number: CD3235-40Q
• Device Lot Number: 3802809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/17/2016
• Initial Date FDA Received: 11/14/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/21/2016; 01/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2012
• 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): Required Intervention