BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 6329141 · Received February 14, 2017

    Report

    Report Number
    9614453-2017-00884
    Event Type
    Malfunction
    Date Received
    February 14, 2017
    Date of Event
    April 7, 2016
    Report Date
    March 17, 2017
    Manufacturer
    MEDTRONIC EUROPE SARL
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD.

    Additional Manufacturer Narrative · 1

    PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2015, PRODUCT TYPE: LEAD. PRODUCT ID: NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2015, PRODUCT TYPE: EXTENSION. PRODUCT ID: NEU_UNKNOWN_EXT, SERIAL# UNKNOWN, IMPLANTED: (B)(6) 2015, PRODUCT TYPE: EXTENSION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT IT WAS UNKNOWN WHAT THE LEAD SERIAL/LOT NUMBERS WERE. IT WAS ALSO STATED THAT THE CAUSE OF THE MALPOSITIONING WAS THAT THE DEVICE WAS NOT IMPLANTED WELL THE FIRST TIME; HUMAN ERROR WAS NOTED. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) OF A CLINICAL STUDY VIA A MANUFACTURER REPRESENTATIVE (REP). IT WAS REPORTED THAT THERE WAS NO EFFECT OF THE DEEP BRAIN STIMULATION (DBS) ON THE PATIENT AS THE LEFT ELECTRODE WAS NOT POSITIONED WELL AND WAS NOT EFFECTIVE DUE TO THE POSITIONING; "MALPOSITION AFTER INITIAL SURGERY". IT WAS CONFIRMED THAT THERE WERE NO RELEVANT SIGNS AND/OR SYMPTOMS FOR THE PATIENT AND THE HEALTH CARE PROVIDER (HCP) FOUND OUT ABOUT THE ISSUE POST-OPERATIVELY.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTH CARE PROVIDER (HCP) OF A CLINICAL STUDY VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH A NEUROSTIMULATOR FOR EPILEPSY. IT WAS REPORTED THAT THERE WAS NO DEEP BRAIN STIMULATION (DBS) EFFECT ON THE PATIENT. IT WAS ALSO NOTED THAT A LEFT ELECTRODE EXTENSION WAS REPOSITIONED ON (B)(6) 2016 AND THE PATIENT WAS HOSPITALIZED FOR TWO DAYS; NO DIAGNOSTICS WERE PERFORMED. THE LEAD WAS STATED TO HAVE BEEN MODIFIED ON AN UNKNOWN DATE. IT WAS NOTED THAT "THE NEUROSURGEON FOUND OUT PREOP". THE RELATEDNESS WAS STATED TO BE PROCEDURE RELATED AND LEFT LEAD RELATED. THE IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNED "ON" ON (B)(6) 2016. THE ISSUE WAS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2016. THERE WERE NO RELEVANT SIGNS AND/OR SYMPTOMS FOR THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111895 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC EUROPE SARL 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R