BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 7593077 · Received June 12, 2018

    Report

    Report Number
    3004209178-2018-13232
    Event Type
    Injury
    Date Received
    June 12, 2018
    Date of Event
    November 10, 2017
    Report Date
    June 29, 2018
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    UDI-DI
    00613994761088
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 37602; SERIAL# (B)(4); IMPLANTED: (B)(6) 2017; PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 7482A51; SERIAL# (B)(4); IMPLANTED: (B)(6) 2008; PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387-40; LOT# J0235589V; IMPLANTED: (B)(6) 2003; PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 7482A51, SERIAL/LOT #: (B)(4), (B)(6), (B)(4); PRODUCT ID: 3387-40, SERIAL/LOT #: (B)(4), (B)(6), (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED: IT WAS REPORTED THAT THE CAUSE OF THE IMPEDANCE ISSUES WAS UNKNOWN. THE ISSUE WAS HOWEVER RESOLVED. THE PATIENT'S THERAPY SETTINGS WERE CASE +1- AND THOSE IMPEDANCES WERE NORMAL. TECH SERVICES WERE COMFROTABLE WITH THE IMPEDANCE AFTER THE PROCEDURE. THERE WERE NO FURTHER COMPLICATIONS REPORTED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA A MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR PARKINSON¿S DUAL AND MOVEMENT DISORDERS. ADDITIONAL INFORMATION WAS RECEIVED FROM THE REP REPORTING THAT THE PATIENT HAD THEIR INS AND EXTENSION REPLACED TODAY DUE TO IMPEDANCE ISSUES. THE REP REPORTED THE FOLLOWING PRE-OP IMPEDANCES ON THE OLD INS/EXTENSION: C1: 520 OHMS C2: 216 OHMS 23: 34 OHMS THE REP REPORTED THE FOLLOWING POST OPERATIVE IMPEDANCE ON THE REPLACEMENT INS/EXTENSION C0: 934 OHMS C1: 982 OHMS - 3.7MA C2: 502 OHMS C3: 502 OHMS 01: 1486 OHMS 02: 1173 OHMS 03: 1173 OHMS 12: 1150 OHMS 13: 1150 OHMS 23: 34 OHMS THE REP REPORTED THAT THE PATIENT WAS PROGRAMMED WITH C1: 982 OHMS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435168 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37603 00613994761088

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention