BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3032397 · Received April 3, 2013

    Report

    Report Number
    3004209178-2013-04518
    Event Type
    Malfunction
    Date Received
    April 3, 2013
    Report Date
    March 14, 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
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3387S-40 LOT# V515921, IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3387S-40 LOT# V443598, IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 37085-60 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 37085-60 LOT# SERIAL# (B)(4), IMPLANTED: 2010 (B)(6), PRODUCT TYPE EXTENSION PRODUCT ID: 3387S-40 LOT# V515921, IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD PRODUCT ID: 3387S-40 LOT# V443598, IMPLANTED: 2010 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED ON (B)(6) 2013, THE PATIENT HAD SOME "EXTREMELY PAINFUL LIKE SPASMS" IN HIS LEFT ARM THAT STARTED WITH TINGLING AND NUMBNESS IN FINGERS. THE PATIENT NOTED IT WORKED ITS WAY UP HIS ARM AND "GOT REAL SORE IN THE FOREARM, IN THE MUSCLE AND IN THE SHOULDER". IT WAS ALSO STATED THAT IT WAS SO BAD THE LAST COUPLE OF DAYS BEFORE REPORT THAT IT BROUGHT THE PATIENT TO HIS KNEES. THE PATIENT SAW HIS GENERAL PRACTITIONER YESTERDAY AND HAD AN X-RAY, WHERE THE PATIENT WAS ON THE FLOOR A COUPLE TIMES IN PAIN. THE PAIN WAS "LIKE A SPASM THAT WOULD COME ON FOR 5-10 MINUTES AND WAS ALMOST UNBEARABLE AND THEN WOULD GO AWAY". IT WAS NOTED THE PATIENT WAS ON PAIN MEDICATION AT THE TIME OF REPORT. THE PAIN STARTED ABOUT TWO MONTHS PRIOR TO REPORT WITH THE TINGLING AND NUMBNESS AND THE PATIENT INITIALLY THOUGHT HE WAS HAVING A HEART RELATED ISSUE. THE PATIENT WAS REDIRECTED TO HIS HEALTHCARE PROVIDER (HCP). IT WAS LATER REPORTED ON (B)(6) 2013 BY THE HCP THE CAUSE OF EVENT WAS UNKNOWN; THERE WERE NO ABNORMAL IMPEDANCES ON THE RIGHT LEAD, BUT FOUND HIGH IMPEDANCE VALUE ON THE LEFT LEAD AT UNIPOLAR PAIR C<(>&<)>0 = 2414 OHMS; PATIENT SYMPTOMS WERE NOTED AS "LEFT SHOULDER/ARM DISCOMFORT FOR ONE MONTH, HAND FEELING NUMB, RADIATE FROM BEHIND SHOULDER BLADE, DOWN ARM INTO FINGERS" AND PATIENT OUTCOME REPORTED AS NO INJURY. IT WAS REPORTED ON (B)(6) 2013 BY THE PATIENT THAT THEY DID NOT HAVE ANY CONCERNS WITH HIS DEVICE/THERAPY

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    136439 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1