BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3371975 · Received September 26, 2013

    Report

    Report Number
    3004209178-2013-17057
    Event Type
    Injury
    Date Received
    September 26, 2013
    Report Date
    May 8, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP WAS NOT CONDUCTED BECAUSE THE PATIENT/PHYSICIAN IS PART OF A MEDTRONIC CLINICAL STUDY, AND THE CLINICAL REPORT FORM TAKES THE PLACE OF A LETTER TO THE PHYSICIAN. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS INFORMATION WILL BE COLLECTED PER THE MEDTRONIC CLINICAL STUDY¿S PROTOCOL, AND THE PRODUCT EVENT RECORD WILL BE UPDATED. THE NEUROSTIMULATOR REMAINS IMPLANTED. THE EVENT DID NOT ALLEGE A POTENTIAL MANUFACTURING ISSUE; THEREFORE, A DHR REVIEW WAS NOT REQUIRED FOR THE NEUROSTIMULATOR. THE EVENT WAS REVIEWED FOR PREVIOUS INVESTIGATIONS AND NONE APPLIED. THE EVENT WAS REVIEWED FOR KNOWN INHERENT RISKS LISTED IN PRODUCT LABELING AND NONE WERE NOTED. REVIEWED FOR ESCALATION TO NCET AND ESCALATION WAS NOT REQUIRED. THERE WERE NO REMEDIAL ACTIONS TAKEN AS A RESULT OF THE EVENT. THE INVESTIGATION OF THE NEUROSTIMULATOR IS INCONCLUSIVE BECAUSE OF INSUFFICIENT EVENT INFORMATION. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387S-40, LOT# V020895, IMPLANTED: (B)(6) 2007. PRODUCT TYPE: LEAD: PRODUCT ID 3387S-40, LOT# V020895, IMPLANTED: (B)(6) 2007. PRODUCT TYPE: LEAD: PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: EXTENSION: PRODUCT ID 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: EXTENSION: PRODUCT ID 7436, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007. PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A RASH ON THE RIGHT SIDE OF THE CHEST AT THE IMPLANTABLE NEUROSTIMULATOR (INS) POCKET SITE SECONDARY TO NEUROSTIMULATOR REPLACEMENT. IT WAS STATED THAT THE EVENT WAS ONGOING. MEDROL PACK WAS ADMINISTERED AS AN INTERVENTION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE ADVERSE EVENT WAS A SURGERY/ANESTHESIA RASH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487699 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 00050 YR