MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR; DEFIBRILLATION LEAD

Model Number LDA210Q/58

Device Problems Failure to Capture (1081); Retraction Problem (1536); Invalid Sensing (2293); Device Dislodged or Dislocated (2923)

Patient Problem Twiddlers Syndrome (2114)

Event Date 09/20/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during in-clinic follow-up, the lead was found to have inappropriate sensing and loss of capture.X-ray revealed the device header facing the opposite direction to what was seen on the original post-op x-ray, and lead was hanging straight in the inferior vena cava/right atrium.Upon opening the pocket, lead was found curled up on top of the device.Twiddlers syndrome was suspected.It was also noted that the lead could not be retracted.The lead was explanted and replaced with no issue.The device was connected with new lead and inserted into medtronic tyrx and a new deeper pocket was created.Patient was stable during and post procedure.

Manufacturer Narrative

Analysis was normal.No anomalies were found.

• Brand Name: OPTISURE ACTIVE FIXATION, DF-4 CONNECTOR
• Type of Device: DEFIBRILLATION LEAD
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 15900 valley view court; sylmar CA 91342
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE); 15900 valley view court; sylmar CA 91342
• Manufacturer Contact: jaime chavez ; 645 almanor avenue; sunnyvale, CA 94085 ; 8184934022
• MDR Report Key: 6023406
• MDR Text Key: 57185246
• Report Number: 2938836-2016-12643
• Device Sequence Number: 1
• Product Code: NVY
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P950022
• 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,Followup
• Report Date: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/30/2019
• Device Model Number: LDA210Q/58
• Device Lot Number: A000022988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2016
• 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: CD1377-36QC 1179254
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR