MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) UNIFY QUADRA CRT-D, US MODEL, DF1COMP; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3249-40

Device Problems Component Missing (2306); Connection Problem (2900)

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

Event Date 09/26/2018

Event Type  malfunction  

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 during the implant procedure, the left ventricular lead could not be fixed properly to the device resulting in ineffective pacing.It was noted that the screw under the silica gel was missing in the device.Device was not used and was replaced successfully.Patient¿s condition was stable.

Manufacturer Narrative

The reported event of missing set screw prior to implant could not be confirmed in the lab.While a set screw was missing and septum was heavily damaged when returned, it is undetermined as to when this occurred.Interrogation of the device revealed the device was above the elective replacement indicator when received.Pacing, sensing, impedance, hv output, patient notifier was tested and no anomaly was detected.The cause of the field event remains undetermined.

• Brand Name: UNIFY QUADRA CRT-D, US MODEL, DF1COMP
• 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
• Manufacturer Contact: robert greenleaf ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 7927295
• MDR Text Key: 122455945
• Report Number: 2938836-2018-11053
• Device Sequence Number: 1
• Product Code: NIK
• UDI-Device Identifier: 05414734504539
• UDI-Public: 05414734504539
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: CD3249-40
• Device Catalogue Number: CD3249-40
• Device Lot Number: S000062071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2018
• 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 Age: 66 YR
• Patient Weight: 66