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

Model Number CD1211-36

Device Problems Migration or Expulsion of Device (1395); Low Sensing Threshold (2575)

Patient Problem Twiddlers Syndrome (2114)

Event Date 07/28/2020

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: 2017865-2020-11562.It was reported that the patient presented for a routine generator change.Upon interrogation, it was noted that the implantable cardioverter defibrillator exhibited low r-wave sensing on the right ventricular lead.It was noted that the patient had occasionally twiddled with their device and moved the device in the pocket.During the procedure, it was noted that the right ventricular lead had pulled back and there was outer insulation damage due to the lead rubbing against the device.The low r-waves was believed to be due to the device pulling back the lead when it was moved in the pocket.The device and lead were explanted and replaced.Patient was stable.

• Brand Name: CURRENT PLUS VR
• Type of Device: IMPLANTABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SYLMAR); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: sonali arangil ; 15900 valley view court; sylmar, CA 91342
• MDR Report Key: 10415820
• MDR Text Key: 203191715
• Report Number: 2017865-2020-11560
• Device Sequence Number: 1
• Product Code: NVZ
• UDI-Device Identifier: 05414734503686
• UDI-Public: 05414734503686
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P910023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/17/2020

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: 11/30/2010
• Device Model Number: CD1211-36
• Device Catalogue Number: CD1211-36
• Device Lot Number: 2794126
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/28/2020
• Initial Date FDA Received: 08/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2009
• 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
• Treatment: DURATA STS OPTIM ACTIVE FIXATION
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 87