BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3182212 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10706
    Event Type
    Injury
    Date Received
    June 21, 2013
    Report Date
    June 3, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3387S-40, LOT# V855467, IMPLANTED: (B)(6) 2012, PRODUCT TYPE: LEAD. PRODUCT ID: 37085-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387S-40, SERIAL# (B)(4), PRODUCT TYPE: LEAD. PRODUCT ID 3387S-40. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS AN ONGOING INFECTION AND THE RIGHT IMPLANTABLE NEUROSTIMULATOR (INS) WAS EXPLANTED (ENTIRE SYSTEM) UNTIL THE INFECTION CLEARED UP. THERE WAS NO REPORTED ISSUE WITH THE THERAPY. IT WAS STATED THAT THE PATIENT WAS TREATED WITH ANTIBIOTICS FOR A CRANIAL WOUND BACK IN (B)(6) 2012 AND THAT SEEMED TO HEAL. THEN IN NOVEMBER 2012, THE EXTENSION CONNECTOR DOWN SHOWED SIGNS OF INFECTION. THE PATIENT WAS SEEN THIS PAST THURSDAY AND THE CONNECTOR WAS VISIBLE, ¿IT WAS OPEN.¿ THERE WAS ALSO A SCAB ON THE SCALP INCISION. IT WAS LATER REPORTED THAT CULTURES WERE POSITIVE FOR STAPHYLOCOCCUS AUREUS. THE CAUSE OF THE CRANIAL WOUND WAS UNKNOWN. THE PATIENT WAS REPORTEDLY DOING FINE NOW. IT WAS ADDED THAT THE PHYSICIAN WAS TO WAIT AT LEAST 6 MONTHS TO RE-IMPLANT THE PATIENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD A SKIN GRAFT FROM HER THIGH ON (B)(6)-2015. HER HEAD INCISION WAS NOT HEALING ON THE RIGHT SIDE. HOWEVER, THERE WAS NO SIGN OF INFECTION.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THEY WENT AHEAD WITH STAGE ONE FOR THE PATIENT THE DAY PRIOR TO REPORT. THEY RE-IMPLANTED WITH THE LEAD ON THE RIGHT SIDE AND DECIDED TO DO A CULTURE. IT STILL SHOWED THERE WERE ABNORMAL WHITE BLOOD CELLS. THE PATIENT WAS CURRENTLY IMPLANTED AND THEY HAD PROCEEDED WITH STAGE ONE AS THE DOCTOR HAD GOTTEN THE RESULTS AFTER IT WAS COMPLETED. IT WAS FURTHER REPORTED 6 DAYS LATER THAT THE PATIENT WAS SUPPOSED TO HAVE THE STAGE 2 PROCEDURE ON THE DAY OF REPORT BUT IT WAS CANCELLED DUE TO NEUROLOGICAL DEFICITS. THE PATIENT WAS VERY CONFUSED AFTER THE STAGE 1 PROCEDURE. THE CT SCAN WAS NORMAL RIGHT AFTER SURGERY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE FOLLOWING DAY. THE PATIENT HAD RETURNED TO THE OPERATING ROOM BECAUSE THE WOUND WAS NOT HEALING PROPERLY. PLASTICS WERE CALLED IN AND THEY DID A GRAFT. THEY PRESENTED TO THE EMERGENCY ROOM A COUPLE OF DAYS LATER WITH CONFUSION. ANOTHER CT WAS PERFORMED AND SHOWED THERE WAS AIR. THE PATIENT WAS CURRENTLY DOING FINE AND WOULD BE DISCHARGED ON THE DAY OF REPORT FROM THE HOSPITAL AND SHE IS NO LONGER CONFUSED. THERE WAS CURRENTLY NO DATE RE-SCHEDULED FOR THE STAGE 2 PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    283284 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 00056 YR Required Intervention