BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LINOX SMART SD 65/16

    MDR report key: 2220017 · Received July 13, 2011

    Report

    Report Number
    1028232-2011-01514
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 2, 2011
    Report Date
    July 5, 2011
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PERFORMANCE OF THE LEAD UNDER COMPLAINT WAS SCRUTINIZED. WITH REGARD TO THE ISSUES AS MENTIONED IN THE COMPLAINT DESCRIPTION, THE ANALYSIS DID NOT SHOW ANY DEVIATIONS FROM THE TECHNICAL SPECIFICATIONS. THE SLIGHTLY DAMAGED SILICONE SEALING OF THE IS-1 CONNECTOR AND THE DEFORMATION OF THE SHOCK COILS OCCURRED MOST LIKELY DURING THE SURGERY. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    OUS MDR - DURING A FOLLOW UP VISIT, MEASUREMENTS SHOWED THAT THE SENSING HAD CHANGED FROM 18.2 MV (AT OPERATION) TO 4.0 MV. F/U ON A SUBSEQUENT VISIT SHOWED UNSTABLE PACING MEASUREMENT THAT VARIED FROM 20.7 MV TO 5.3 MV. THE PHYSICIAN CHECKED TO SEE IF THE LEAD DISLODGED AND FOUND NO ABNORMALITY. ON (B)(6), SHOCK-THERAPY WAS DELIVERED 5 TIMES AND THE PT WAS ADMITTED TO THE HOSP WHERE T-WAVE OVERSENSING WAS CONFIRMED. ON (B)(6), THE PT UNDERWENT A SURGICAL PROCEDURE AND THIS LEAD WAS EXPLANTED AND REPLACED WITH A COMPETITIVE LEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LINOX SMART SD 65/16 ICD LEAD NVY BIOTRONIK SE & CO. KG 359066

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization