BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLIA S 60

    MDR report key: 8621545 · Received May 17, 2019

    Report

    Report Number
    1028232-2019-02029
    Event Type
    Malfunction
    Date Received
    May 17, 2019
    Date of Event
    May 7, 2019
    Report Date
    May 10, 2019
    Manufacturer
    BIOTRONIK SE & CO. KG
    Product Code
    NVN
    UDI-DI
    04035479118273
    PMA / PMN Number
    P950037
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS CURRENTLY NOT AVAILABLE FOR ANALYSIS. NO CONCLUSION CAN BE DRAWN AT THIS TIME. THE INVESTIGATION WILL BE RE-OPENED SHOULD ADDITIONAL DATA BECOME AVAILABLE.

    Additional Manufacturer Narrative · 0

    UPON RECEIPT, THE LEAD UNDER COMPLAINT WAS SUBJECTED TO AN EXTENSIVE ANALYSIS. THE PERFORMANCE OF THE DEVICE WAS SCRUTINIZED, INCLUDING A VISUAL AND ELECTRICAL INSPECTION. THE VISUAL INSPECTION OF THE LEAD SHOWED ABRASION MARKS ALONG THE LEAD BODY. FURTHER INSPECTION REVEALED A DAMAGED INSULATION APPROXIMATELY 26CM DISTAL TO THE IS-1 CONNECTOR PIN. IN THAT SECTION, THE LEAD BODY WAS FOUND SQUEEZED AND DEFORMED. BASED ON THE CHARACTERISTICS AS WELL AS THE LOCATION OF THE DAMAGE, IT IS REASONABLE TO ASSUME THAT THE LEAD HAD BEEN SUBJECT TO EXCESSIVE MECHANICAL FORCES AS THE RESULT OF CLAVICULAR FIRST RIB ENTRAPMENT. IN ADDITION, CUTS IN THE INSULATION WERE OBSERVED WHICH OCCURRED MOST LIKELY DURING THE EXTRACTION PROCEDURE. THE MANUFACTURING PROCESS FOR THIS LEAD WAS RE-INVESTIGATED. ALL PRODUCTION STEPS HAD BEEN PERFORMED ACCORDINGLY. THERE WAS NO SIGN OF ANY INCONSISTENCY DURING THE MANUFACTURING PROCESS. IN CONCLUSION, THE ANALYSIS DID NOT REVEAL ANY SIGN OF A MATERIAL OR MANUFACTURING PROBLEM.

    Description of Event or Problem · 1

    THIS SYSTEM WAS REMOVED BECAUSE THE RA AND RV LEADS FLIPPED TO UNIPOLAR AND THERE WAS LOSS OF CAPTURE IN UNIPOLAR. THE PHYSICIAN CHOSE TO REPLACE THE WHOLE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413583 SOLIA S 60 PACING LEAD NVN BIOTRONIK SE & CO. KG 377179 04035479118273

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization