BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 7404691 · Received April 6, 2018

    Report

    Report Number
    3007566237-2018-01005
    Event Type
    Injury
    Date Received
    April 6, 2018
    Date of Event
    April 3, 2018
    Report Date
    October 31, 2019
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2019, PRODUCT TYPE: EXTENSION; PRODUCT ID: 3387S-40, LOT# V052560, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2019, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2019, PRODUCT TYPE: EXTENSION; PRODUCT ID: 3387S-40, LOT# V052560, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2019, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER VIA A MANUFACTURER REPRESENTATIVE. IT WAS REPORTED THAT THE X-RAY IDENTIFIED A RIGHT LEAD FRACTURE. THE PATIENT HAD REPORTED A FALL PRIOR TO THE FRACTURE BEING IDENTIFIED. THE NECK EXTENSION HAD ALSO MIGRATED DOWN THEIR NECK WITH THE CONNECTOR SITE BEING SEEN IN THEIR NECK VIA X-RAY. THE EXTENSION WAS REPLACED DUE TO THE MIGRATION AND THE RIGHT LEAD WAS REPLACED. THE IMPEDANCE CHECK WAS ABNORMAL. THE ISSUE WAS RESOLVED AT THE TIME OF THE REPORT. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM THE MANUFACTURER REPRESENTATIVE (REP) STATING THAT THE DATE AND CAUSE OF THE FALL WERE UNKNOWN.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3387S-40, LOT# V052560, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. OTHER RELEVANT DEVICE(S) ARE: PRODUCT ID: 3387S-40, SERIAL/LOT #: (B)(6) , UBD: 27-FEB-2010, (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. PATIENT INFORMATION AND DEVICE INFORMATION WAS UPDATED. THE ISSUE REMAINS UNRESOLVED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A HEALTHCARE PROVIDER (HCP) VIA MANUFACTURER REPRESENTATIVE (REP) REGARDING A PATIENT WHO WAS IMPLANTED WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THE RIGHT LEAD WAS FRACTURED, FOUND BY AN X-RAY. THE PATIENT'S THERAPY WASN'T WORKING. THE RIGHT SIDE IMPEDANCES WERE FOUND TO BE HIGH. A FUTURE LEAD REPLACEMENT IS PLANNED. THE ISSUE IS UNRESOLVED AT THIS TIME. NO FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    245470 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention