BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 7975268 · Received October 17, 2018

    Report

    Report Number
    3004209178-2018-23273
    Event Type
    Malfunction
    Date Received
    October 17, 2018
    Date of Event
    October 13, 2018
    Report Date
    January 10, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00643169529762
    PMA / PMN Number
    P960009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 37761, SERIAL# UNKNOWN, PRODUCT TYPE RECHARGER. EVALUATION OF THE RECHARGER REVEALED THE CONNECTOR PINS WERE BROKEN. (B)(4)NOW APPLY. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE CONSUMER REPORTED THE BROKEN CONNECTOR AND DEPLETED NEUROSTIMULATOR WAS FIRST NOTICED ON OCTOBER 13, 2018. THE CONSUMER ALSO NOTED THE REPLACEMENT OF THE DESKTOP CHARGER RESOLVED THE DEPLETED NEUROSTIMULATOR. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE ANTICIPATED.

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE : PRODUCT ID: 37761, SERIAL# UNKNOWN, PRODUCT TYPE: RECHARGER. PRODUCT ID: 37761, SERIAL/LOT #: UNKNOWN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEURO STIMULATOR (INS) FOR MOVEMENT DISORDERS. IT WAS REPORTED THAT THE CONNECTOR PIN WAS BROKEN AND STUCK INSIDE THE INS RECHARGER (INSR). IT WAS MENTIONED THAT THE PATIENT'S INS CHARGE WAS AT ZERO BECAUSE THE NURSING FACILITY WHERE THE PATIENT RESIDES DID NOT NOTIFY THE CALLER SOONER. NO OUT OF BOX FAILURE WAS REPORTED. THERE WAS NO REPORTED MEDICAL/THERAPY PROBLEMS RELATED TO THE SMALL PART COMPONENTS PRODUCT. NO PATIENT SYMPTOMS WERE REPORTED. IT WAS ALSO NOTED THAT THE BROKEN CONNECTOR PIN WAS SUCCESSFULLY REMOVED FROM THE INSR , SO THE PATIENT WILL ONLY BE RECEIVING A DESKTOP CHARGER (DTC). A REPLACEMENT DTC WAS SENT TO THE PATIENT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED/ ANTICIPATED AS A RESULT OF THIS EVENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816111 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37612 00643169529762

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR