BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IMPLANTABLE LEAD

    MDR report key: 3904573 · Received July 1, 2014

    Report

    Report Number
    2124215-2014-09794
    Event Type
    Malfunction
    Date Received
    July 1, 2014
    Date of Event
    April 17, 2014
    Report Date
    May 30, 2014
    Manufacturer
    GUIDANT PUERTO RICO BV
    Product Code
    LWS
    PMA / PMN Number
    P910073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AS NO FURTHER INFORMATION CONCERNING THIS REPORT IS EXPECTED, OUR INVESTIGATION IS COMPLETE. THIS INVESTIGATION WILL BE UPDATED SHOULD FURTHER INFORMATION BE PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, THE RATE/SENSE NEGATIVE CONDUCTOR COIL WAS FRACTURED APPROXIMATELY 372 MM TO 373 MM FROM THE TIP. THE LOCATION OF THE FRACTURE IS DISTAL OF THE SUTURE SLEEVE TIE DOWN AREA. THE TYPE OF FRACTURE ON THE LEAD IS CONSISTENT WITH A FATIGUE FRACTURE ON A RELIANCE LEAD.

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE RETURNED PRODUCT IS CURRENTLY ONGOING. THIS EVENT WILL BE UPDATED UPON COMPLETION OF THE ANALYSIS.

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THIS LEAD WAS RETURNED FOR RELIABILITY ANALYSIS.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE LEAD WAS RETURNED FOR RELIABILITY ANALYSIS.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THE PATIENT WITH THIS DEVICE SYSTEM WAS WEARING A BLUETOOTH SYSTEM AROUND THE NECK FOR USE WITH CELL PHONE. WHEN EXITING A MOTOR VEHICLE WITH THE CELL PHONE ON THE DASH, THE PATIENT RECEIVED A SHOCK, AS WELL AS WHEN RE-ENTERING THE VEHICLE. UPON FURTHER REVIEW, AN EPISODE WITH LARGE NOISE ON THE VENTRICULAR ELECTROGRAM (EGM) WAS SENSED ON THE VENTRICULAR CHANNEL, RESULTING IN A 21J AND 31J SHOCK. ADDITIONALLY, THREE DIVERTED SHOCKS WERE OBSERVED IN THE SAME EPISODE. SEVERAL OTHER EPISODES WERE OBSERVED ON THE SAME DAY. ISOMETRIC EXERCISES PRODUCED SHORT BURSTS OF NOISE. A CHEST XRAY WAS PERFORMED AND SHOWED NO VISIBLE FRACTURE. THE PHYSICIAN BELIEVED THERE TO BE A POSSIBLE SET SCREW ISSUE. THE PHYSICIAN REPROGRAMMED THE DEVICE TO MONITOR ONLY AND A REVISION PROCEDURE WAS SCHEDULED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED THAT THE RV LEAD WAS EXTRACTED DUE TO A FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383101 IMPLANTABLE LEAD LWS GUIDANT PUERTO RICO BV

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR 0185| 4244| T167