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

Model Number CD1411-36Q

Device Problem High Capture Threshold (3266)

Patient Problems Unspecified Infection (1930); Pocket Erosion (2013); Twiddlers Syndrome (2114)

Event Date 08/27/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that patient "twiddled" the device and exposed the implantable cardioverter defibrillator outside of the chest wall resulting in infection.High capture thresholds were also reported on the right ventricular lead.Both the device and lead were explanted.Patient was in stable condition.Related manufacturer reference number: 2017865-2020-12507.

Manufacturer Narrative

The reported event of inadequate capture threshold was not confirmed.Analysis was normal.No anomalies were found.

• Brand Name: ELLIPSE VR
• 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: 10538747
• MDR Text Key: 207093184
• Report Number: 2017865-2020-12506
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734507738
• UDI-Public: 05414734507738
• Combination Product (y/n): N
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/15/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: CD1411-36Q
• Device Catalogue Number: CD1411-36Q
• Device Lot Number: A000075423
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/27/2020
• Initial Date FDA Received: 09/15/2020
• Supplement Dates Manufacturer Received: 09/28/2020
• Supplement Dates FDA Received: 10/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR; DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR