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

Model Number CD3231-40Q

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Fatigue (1849); Low Blood Pressure/ Hypotension (1914)

Event Date 04/26/2018

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

It was reported that the patient began experiencing symptoms of fatigue in (b)(6) of 2018.The patient was brought to the hospital for an implantable cardioverter defibrillator replacement procedure on (b)(6) 2018.However, the procedure was only attempted but not completed.The device was then replaced on (b)(6) 2018.No further information was available.

Event Description

New information received noted that the implantable cardioverter defibrillator was removed during a lead extraction procedure.The left ventricular lead, right ventricular lead, and atrial lead were all explanted and replaced due to unspecified malfunction and lead fracture.During the procedure the patient experienced a transient episode of hypotension.Fluoroscopy imaging did not demonstrate significant pericardial effusion and heart borders remained of normal contour.The patient was hemodynamically stable throughout and post procedure.

• Brand Name: UNIFY CRT-D
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7792032
• MDR Text Key: 117420071
• Report Number: 2017865-2018-12080
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734504393
• UDI-Public: 05414734504393
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2013
• Device Model Number: CD3231-40Q
• Device Catalogue Number: CD3231-40Q
• Device Lot Number: 3470631
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/26/2018
• Initial Date FDA Received: 08/16/2018
• Supplement Dates Manufacturer Received: 09/12/2018
• Supplement Dates FDA Received: 10/04/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2011
• 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
• Patient Outcome(s): Required Intervention