BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3971712 · Received July 31, 2014

    Report

    Report Number
    3004209178-2014-13784
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 8, 2014
    Report Date
    May 23, 2018
    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: PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), EXPLANTED: 2014-(B)(6), PRODUCT TYPE EXTENSION, PRODUCT ID 3708660, SERIAL# (B)(4), IMPLANTED: 2012-(B)(6), EXPLANTED: 2014-(B)(6), PRODUCT TYPE EXTENSION. PRODUCT ID 3389S-40, LOT# VA037LU, IMPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD, PRODUCT ID 3389S-40, LOT# VA037LU, IMPLANTED: 2012-(B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 3708660 (B)(4) IMPLANTED: (B)(6)2012 EXPLANTED: (B)(6)2014 PRODUCT TYPE EXTENSION PRODUCT ID 3708660 (B)(4) IMPLANTED: (B)(6)2012 EXPLANTED: (B)(6)2014 PRODUCT TYPE EXTENSION PRODUCT ID 3389S-40 LOT# (B)(4) IMPLANTED: (B)(6)2012 PRODUCT TYPE LEAD PRODUCT ID 3389S-40 LOT# (B)(4) IMPLANTED: (B)(6)2012 PRODUCT TYPE LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WOULD NOT BE RECEIVING A REPLACEMENT UNIT AS SYMPTOMS WERE TOLERATED WITHOUT. THE OUTCOME WAS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2014.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A SMALL ESCHAR OVER THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE. IT WAS NOTED THAT THE OUTCOME WAS AN ONGOING EVENT. IT WAS NOTED THAT THE DIAGNOSTIC METHODS INCLUDED EXAMINATION/PALPATION AND RESULTED IN PURULENT DISCHARGE ON 2014-(B)(6). IT WAS NOTED THAT THE EVENT WAS UNLIKELY RELATED TO THE DEVICE OR THERAPY AND POSSIBLY RELATED TO THE IMPLANT PROCEDURES. IT WAS NOTED THAT SIGNS OR SYMPTOMS INCLUDED SKIN BREAKDOWN OVER THE INS SITE AND PURULENT DISCHARGE. IT WAS NOTED THAT THE EVENT SEVERITY WAS MILD. IT WAS NOTED THAT THE EVENT RESULTED IN IN-PATIENT HOSPITALIZATION. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THERE WAS NO ALLEGED PRODUCT ISSUE. IT WAS NOTED THAT ACTIONS REQUIRED AS A RESULT OF THE EVENT INCLUDED EXPLANT. IT WAS NOTED THAT THE PATIENT SHOWED UP AT THE ER WITH THE IMPLANTABLE NEUROSTIMULATOR (INS) ERODING THOUGH THE SKIN AT THE IMPLANT SITE IN THE CHEST. IT WAS NOTED THAT IT WAS VISIBLE AND THE RISK OF INFECTION WAS VERY HIGH. IT WAS NOTED THAT THE INS AND EXTENSIONS WERE REMOVED IN HOPES OF SALVAGING THE LEADS. IT WAS NOTED THAT THE PATIENT¿S STATUS AT THE TIME OF REPORT WAS ALIVE WITH NO INJURY. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE INS AND EXTENSION HARDWARE WAS REMOVED. IT WAS NOTED THAT INTERVENTIONS INCLUDED INDURATED AREA OVER SITE OF THE INS CAUSE FOR CONCERN AND REMOVAL OF THE HARDWARE ON 2014-(B)(6).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED CONFIRMED THAT THERE WAS AN INFECTION PRESENT, AND THAT THE PATIENT WILL NOT BE RECEIVING A REPLACEMENT AS SYMPTOMS ARE TOLERATED WITHOUT IT. A PATIENT DISCONTINUATION FORM IS TO BE COMPLETED. NO FURTHER COMPLICATIONS ARE ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447311 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR Hospitalization| R