MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. QUADRA ASSURA MP ICD; IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Model Number CD3371-40QC

Device Problems Failure to Capture (1081); Device Contamination with Body Fluid (2317); Device Sensing Problem (2917)

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

Event Date 07/02/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

During follow-up, approximately two weeks after the implant procedure, the pacing impedance of the right ventricular (rv) lead was high and out of range.In addition, failure to capture and low sensing was observed.Abbott technical support was contacted and recommended a revision procedure.The patient underwent surgery, the icd was removed and blood was observed in the rv channel of the header.The electrical values of the rv lead were measured with a pacing system analyzer and all electrical values were in range.The device was explanted and replaced to resolve the event.The patient was stable before, during and after the procedure.

Manufacturer Narrative

The device was returned for analysis and after decontamination, a visual inspection was performed and no anomalies were observed.The reported field event of high impedance was verified in the data stored in the device.The device¿s data showed the ventricular pacing lead impedance measurements were high starting on (b)(6) 2020.The device underwent testing including impedance, sensing, pacing, and high voltage shock output and no anomalies were found.All impedances measured in the lab were normal.The cause of the reported events could not be determined.

• Brand Name: QUADRA ASSURA MP ICD
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 645 almanor avenue; sunnyvale CA 94085
• MDR Report Key: 10250936
• MDR Text Key: 198121779
• Report Number: 2938836-2020-07328
• 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: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: CD3371-40QC
• Device Lot Number: P000099956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention