BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4121833 · Received September 26, 2014

    Report

    Report Number
    3004209178-2014-17798
    Event Type
    Injury
    Date Received
    September 26, 2014
    Report Date
    September 3, 2014
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 37651, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 3387S-40, LOT# V046959, IMPLANTED: (B)(6) 2007, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT'S INFECTION HAD RESOLVED AND THE PATIENT WAS ALL CLEAR. RE-IMPLANTATION HAD BEEN SCHEDULED AND THE PATIENT'S SURGICAL STAGES WOULD CONCLUDE ON (B)(6)2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S ENTIRE SYSTEM WAS EXPLANTED SECONDARY TO AN INFECTIOUS COMPLICATION. OVER THE PAST SEVERAL MONTHS THE PATIENT BEGAN NOTICING INFLAMMATION AND EROSION OF THE LEAD FROM THE RIGHT PARIETAL INCISION SITE WITHOUT ANY PRECEDENT TRAUMA. THE PATIENT¿S WIFE CALLED THE CLINIC ON (B)(6) 2014 TO INFORM THEM ¿HE NOTICED HIS WIRES STICKING THROUGH HIS SCALP WHEN HE GOT HIS HAIRCUT LAST WEEK.¿ THIS RESULTED IN THE EROSION OF THE LEADS THROUGH HIS SKIN AND SUBSEQUENT TENDERNESS IN THE RETRO-AURICULAR REGION NEAR THE CONNECTORS. THE DOCTOR DEEMED THAT THE SYSTEM WAS ALREADY COLONIZED AND INFECTION AND IT SHOULD JUST BE REMOVED PRIOR TO REPLACEMENT. NO CULTURE WAS PERFORMED AND THE ONSET OF THE INFECTION WAS NOT SPECIFIED. IT WAS NOT MENINGITIS. THE DOCTOR INTENDED TO RE-IMPLANT THE PATIENT IN (B)(6). HE WAS RECOVERING AS PLANNED WITH NO UNEXPECTED COMPLICATIONS. IT WAS TOO EARLY TO KNOW IF THE INFECTION HAD RESOLVED. IT WAS TOO EARLY TO KNOW IF THE INFECTION HAD RESOLVED, SO ADDITIONAL INFORMATION WAS REQUESTED FOR A LATER DATE. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT. REFER TO MANUFACTURING REPORT #3004209178-2014-02704 AS THE PATIENT HAD SURGERY PRIOR TO THIS EXPLANT TO REPLACE ERODING EXTENSIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601780 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37612

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention