MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) QUADRA ASSURA MP ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3371-40C

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Vascular Dissection (3160)

Event Date 04/25/2019

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.Further information was requested but not received.

Event Description

Related manufacturer reference numbers: 2938836-2019-04638, 2938836-2019-04640 and 2938836-2019-04641.It was reported that during the implant procedure, there was a coronary sinus dissection.There was no complication due to the dissection.The patient was discharge after an overnight observation on (b)(6) 2019.The patient was doing well before during and after the event.It was unknown which product caused the dissection.

Manufacturer Narrative

Correction: new information states that there was no allegation against the crtd system.Dissection of the coronary sinus happened during cannulation tentative of the coronary sinus.Dissection happened while using the cannulator which is reported in manufacturer report number 2182269-2019-00055.

Event Description

New information states that there was no allegation against the crtd system.Dissection of the coronary sinus happened during cannulation tentative of the coronary sinus.Dissection happened while using the cannulator which is reported in manufacturer report number 2182269-2019-00055.

• Brand Name: QUADRA ASSURA MP ICD
• 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: elizabeth boltz ; 15900 valley view court; sylmar, CA 91342 ; 8184932577
• MDR Report Key: 8685431
• MDR Text Key: 147559810
• Report Number: 2938836-2019-04637
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 06/11/2019

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: 04/30/2020
• Device Model Number: CD3371-40C
• Device Lot Number: P000062741
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/27/2019
• Initial Date FDA Received: 06/10/2019
• Supplement Dates Manufacturer Received: 06/11/2019
• Supplement Dates FDA Received: 06/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/29/2018
• 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 Outcome(s): Required Intervention
• Patient Age: 76 YR