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

Model Number CD3371-40C

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Pocket Erosion (2013)

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

Related manufacturer reference number: 2017865-2020-15350, 2017865-2020-15351.It was reported that the patient experienced an infection.The cardiac resynchronization therapy defibrillator had eroded through the skin.Wound cultures were performed and were positive for a bacterial infection.The cause of infection was due to the upgrade procedure that was performed on (b)(6) 2020.There were no allegation that the device and leads caused the infection.The patient presented for explant on (b)(6) 2020.Upon explanting the final lead, the patient¿s blood pressure started to drop precipitously and the physician had to perform an emergency open heart surgery.The leads and device were successfully explanted.The patient was recovering and received oral antibiotics.

Manufacturer Narrative

Interrogation of the device revealed it was above eri when received.Based on this information, the device was found to communicate appropriately with a merlin programmer and has not reached the elective replacement indicator (eri).

• Brand Name: QUADRA ASSURA MP ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• MDR Report Key: 10673675
• MDR Text Key: 211224524
• Report Number: 2017865-2020-15349
• Device Sequence Number: 1
• Product Code: NIK
• Combination Product (y/n): N
• PMA/PMN Number: P030054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 05/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: CD3371-40C
• Device Lot Number: P000085183
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DURATA STS OPTIM ACTIVE FIXATION; QUARTET
• Patient Outcome(s): Required Intervention