BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINOX SMART PROMRI SD 65/16

    MDR report key: 3874195 · Received June 16, 2014

    Report

    Report Number
    1028232-2014-01979
    Event Type
    Injury
    Date Received
    June 16, 2014
    Date of Event
    April 1, 2014
    Report Date
    June 5, 2014
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVY
    PMA / PMN Number
    P980023
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PERFORMANCE OF THE LEADS UNDER COMPLAINT WAS SCRUTINIZED. DURING THE ANALYSIS OF THE LEADS, EXPLANTATION DAMAGES WERE FOUND ON BOTH LEADS. IN PARTICULAR AT THE SOLIA S THE DISTAL PART OF THE LEAD WAS FOUND PARTLY PULLED OUT FROM THE RING ELECTRODE AS MENTIONED IN THE COMPLAINT DESCRIPTION. BASED ON THE CHARACTERISTICS OF THE DAMAGE, IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO EXCESSIVE MECHANICAL FORCES. TRACTION FORCES DURING THE SURGERY SHOULD BE TAKEN INTO CONSIDERATION. DURING FURTHER ANALYSIS NO DEVIATION WERE FOUND, WHICH MIGHT BE RELATED TO THE HIGH IMPEDANCE MENTIONED IN THE CLINICAL OBSERVATION. THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    OUS MDR - THE PATIENT SUFFERS FROM TWIDDLER'S SYNDROME. IN (B)(6) 2013, ABRUPT INCREASES OF THIS LEAD'S PACE/SENSE IMPEDANCES FROM 1000 OHM TO OVER 1500 WERE NOTED VIA HOME MONITORING. IN (B)(6) 2013 THE ICD WAS FOUND OVERTURNED IN THE POCKET, BUT THIS LEAD WAS STILL IN PLACE. ON (B)(6), 2014 THE P/S IMPEDANCE OF THE RV LEAD EXCEEDED 2500 OHM, SO THE SYSTEM WAS EXTRACTED. THE PATIENT IS IN PERMANENT AFIB, SO ONLY THE RV LEAD AND THE ICD WERE IMPLANTED WITH THE ICD BEING PLACED SUB MUSCULARLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352106 LINOX SMART PROMRI SD 65/16 ICD LEAD NVY BIOTRONIK SE & CO. KG 377169

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization