BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4638277 · Received March 27, 2015

    Report

    Report Number
    3004209178-2015-05539
    Event Type
    Injury
    Date Received
    March 27, 2015
    Report Date
    March 9, 2015
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 7 48240, SERIAL# (B)(4), IMPLANTED: (B)(6) 2003, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387S-40, LOT# V093181, IMPLANTED: (B)(6) 2008, PRODUCT TYPE: LEAD. PRODUCT ID: 3387-40, LOT# J0337587V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE: LEAD. PRODUCT ID: 3387-40, LOT# J0337587V, IMPLANTED: (B)(6) 2003, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A40, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37651, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 64001, LOT# N339324, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: ADAPTER. PRODUCT ID: 37612, SERIAL# (B)(6), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT HIGH IMPEDANCES WERE MEASURED ON THE LEFT IMPLANTABLE NEUROSTIMULATOR (INS). THE PATIENT WAS HAVING A TROUBLESHOOTING SURGERY ON (B)(6) 2015 TO REPLACE THE LEFT INS OR EXTENSION. NO SYMPTOMS OR OUTCOME WERE REPORTED REGARDING THIS EVENT. FURTHER FOLLOW-UP IS BEING CONDUCTED TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206921 ACTIVA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00069 YR Required Intervention