BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VANTA

    MDR report key: 12580252 · Received October 5, 2021

    Report

    Report Number
    3004209178-2021-14876
    Event Type
    Malfunction
    Date Received
    October 5, 2021
    Date of Event
    September 8, 2021
    Report Date
    October 5, 2021
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    LGW
    UDI-DI
    00763000411923
    PMA / PMN Number
    P840001
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37714, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2021, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 377760, LOT#: V002340, IMPLANTED: (B)(6) 2006, EXPLANTED: (B)(6) 2021, PRODUCT TYPE: LEAD. PRODUCT ID: 377760, LOT#: V002341, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THE PATIENT WAS HAVING A ROUTINE BATTERY CHANGE FOR AN END OF LIFE BATTERY AND WHEN THEY MADE AND INCISION OF THE BATTERY THEY SAW A WHITE MILK LIKE SECRETION COMING FROM THE SITE. AS THEY STARTED TO DISSECT THE BATTERY THEY NOTICED THERE WAS A FILM LIKE SUBSTANCE ALL OVER THE BATTERY. IT APPEARED TO THE DOCTOR THAT THE WHITE PLASTIC PIECE ON TOP OF THE BATTERY LOOKED AS IF IT WAS SECRETING DOWN AND COVERING THE BATTERY. THEY WOULD BE SENDING THE BATTERY BACK FOR REVIEW. IT WAS NOTED THAT IT WAS DECONTAMINATED SO THE SUBSTANCE CAME OFF OF IT IN THE PROCESS, BUT THE REP SENT PICTURES OF THE BATTERY/BATTERY POCKET PRIOR TO DECONTAMINATION PROCESS. THE BATTERY WAS REMOVED AND A NEW ONE WAS PLACED. IT WAS ALSO NOTED THAT IMPEDANCE ISSUES WERE DISCOVERED ON CONTACTS 6, 7,8, 9, 10, 11, 12 AND 15. IT WAS DECIDED AT THE TIME NOT TO CHANGE OUT THE LEADS AS THE PATIENT WAS SEDATED AND THEY DID NOT HAVE THEIR CONSENT. THEY WOULD SEE IF THEY GOT GOOD PROGRAMMING ON THE CONTACTS THAT WERE GOOD. ON 2021-OCT-01, ADDITIONAL INFORMATION WAS RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) REPORTING THAT THE PATIENT WAS DOING WELL WITH THEIR SCS AFTER THE REPLACEMENT. THE REP RETURNED THE BATTERY FOR ANALYSIS. THEY INDICATED THAT THEY HAD NO FURTHER INFORMATION. RELATED REGULATORY REPORT# 3004209178-2021-14875.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1474745 VANTA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR LGW MEDTRONIC PUERTO RICO OPERATIONS CO. 977006 00763000411923

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR