BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 2616581 · Received June 14, 2012

    Report

    Report Number
    3004209178-2012-04490
    Event Type
    Injury
    Date Received
    June 14, 2012
    Report Date
    May 21, 2012
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID 37085-60 LOT# SERIAL# (B)(4) IMPLANTED: 2011-(B)(6) EXPLANTED: PRODUCT TYP EXTENSION PRODUCT ID 37085-60 LOT# SERIAL# (B)(4) IMPLANTED: 2011-(B)(6) EXPLANTED: PRODUCT TYP EXTENSION PRODUCT ID 3389S-40 LOT# V801522 SERIAL# IMPLANTED: 2011-(B)(6) EXPLANTED: PRODUCT TYP LEAD PRODUCT ID 3389S-40 LOT# V659372 SERIAL# IMPLANTED: 2011-(B)(6) EXPLANTED: PRODUCT TYP LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD A BUMP OVER INS SITE WHICH WAS SWOLLEN, RED AND WARM AT TIMES. THE PATIENT STATED HE STARTED TO NOTICE THE BUMP ABOUT 1 1/2 MONTHS AGO, IN (B)(6) 2012. THE PATIENT WENT TO HIS PHYSICIAN 1 WEEK AFTER HE NOTICED THE BUMP AND THE PHYSICIAN TOLD THE PATIENT TO TURN THE DEVICE OFF TO SEE IF THIS AFFECTED THE BUMP. THE PATIENT SAID THE BUMP REDUCED TO HALF ITS SIZE BUT WAS STILL THERE. THE PATIENT'S PHYSICIAN DID NOT RUN ANY TESTS AT THAT TIME. THE PATIENT ALSO SAW THE PHYSICIAN ABOUT 4 WEEKS AGO, AROUND (B)(6), 2012, AND THE PHYSICIAN SUGGESTED THAT THE PATIENT HAVE THE INS TAKEN OUT. THE PATIENT STATED THEY HAD NOT HAD STIM TURNED ON SINCE THE PHYSICIAN TOLD HIM TO TURN IT OFF. THE PATIENT NEVER HAD ANY ALLERGY TESTING DONE BEFORE THE IMPLANT BUT STATES HE WAS NOT ALLERGIC TO ANYTHING. HE FELT HE HAD BEEN HAVING ISSUES CONCENTRATING FOR THE PAST 2 WEEKS. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED AS OF (B)(6) 2012, THE PATIENT WAS STILL HAVING CONCERNS REGARDING HIS DEVICE OR THERAPY BUT HE HAD A SCHEDULED APPOINTMENT ON (B)(6) 2012. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2012, REPORTED THE PATIENT HAD A SUPERFICIAL INFECTION AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE AND 'EROSION OF SCALP' (UNABLE TO READ CLEARLY). THE PATIENT'S INS WAS EXPLANTED 1-2 MONTHS PRIOR TO THIS REPORT AND THE LEAD WAS SCHEDULED TO BE EXPLANTED ON (B)(6) 2012. IT WAS REPORTED THE PATIENT WAS HOSPITALIZED DUE TO THE EVENT. THE PATIENT RESOLVED WITHOUT SEQUELAE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1