BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3524201 · Received December 17, 2013

    Report

    Report Number
    3004209178-2013-23678
    Event Type
    Injury
    Date Received
    December 17, 2013
    Date of Event
    November 20, 2013
    Report Date
    November 22, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    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

    PRODUCT ID 37642, SERIAL# (B)(4); PRODUCT TYPE PROGRAMMER, PATIENT PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE EXTENSION PRODUCT ID 3387S-40 LOT# VA0214Q, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 3387S-40 LOT# V902308, IMPLANTED: 2012 (B)(6); PRODUCT TYPE LEAD PRODUCT ID 37085-60, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6); PRODUCT TYPE EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS "WEARING THROUGH THE SKIN". IT WAS STATED THAT THE INS WAS SURGICALLY MOVED TO ANOTHER LOCATION. THE INS WAS MOVED TO THE PATIENT'S RIGHT CHEST. IT WAS NOTED THAT THE PATIENT EXPERIENCED POCKET EROSION. IT WAS REPORTED THAT THE PATIENT'S STATUS AT THE TIME OF THE REPORT WAS "ALIVE WITH NO INJURY".

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT EROSION WAS NOTED IN THE PATIENT'S RIGHT CHEST IN THE SUPERIOR LATERAL CORNER OF THE IMPLANTABLE NEUROSTIMULATOR (INS). THREE DAYS PRIOR TO THE REPORT THE PATIENT'S WIFE NOTED REDNESS IN THE SUPERIOR LATERAL CORNER OF THE INS. THE PATIENT'S WIFE ALSO NOTED THAT AFTER THE PATIENT'S PREVIOUS REVISION IN (B)(6) HE WAS TREATED WITH SIX WEEKS OF ANTIBIOTICS AND THE INCISION IN HIS LEFT CHEST WALL HAD NOT HEALED COMPLETELY. THE PATIENT HAD A BIOPSY OF HIS LEFT CHEST WALL THAT CONFIRMED PYOGENIC GRANULOMA SUPERIOR TO THE LEFT CHEST WALL INCISION. THE PATIENT WAS SCHEDULED FOR AN INS REPLACEMENT ON THE DAY OF THE REPORT. THE PATIENT WAS TO BE ADMITTED TO THE HOSPITAL ON THE DAY OF THE REPORT FOR FIVE DAYS TO BE TREATED WITH INTRAVENOUS ANTIBIOTICS. CULTURES WERE OBTAINED FROM THE RIGHT CHEST WALL SITE AND SENT FOR RESULTS. AT THE TIME OF THE REPORT THE PATIENT OUTCOME WAS NOTED AS ALIVE WITH NO INJURY.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE RESULT OF THE CULTURE TAKEN ON (B)(6) 2014 WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    658977 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Hospitalization| R