BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 3050395 · Received April 10, 2013

    Report

    Report Number
    3004209178-2013-05862
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Report Date
    March 25, 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
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3387S-40, LOT# V230715, IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 7482A51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE PATIENT NOTED THEY ¿RECEIVED ASSISTANCE FROM THEIR DOCTOR OR MANUFACTURER REPRESENTATIVE AND THEIR CONCERNS WERE RESOLVED¿ ON (B)(6) 2013 AND THAT THEY WERE ¿STILL HAVING CONCERNS REGARDING THEIR DEVICE OR THERAPY BUT THEY WERE WORKING WITH THEIR DOCTOR OR MANUFACTURER REPRESENTATIVE.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT RECENTLY GOT A NEW IMPLANTABLE NEUROSTIMULATOR (INS) AND WAS GETTING A SHOCKING FEELING. THE REPORTER STATED THAT WHEN THE PATIENT GOT THE SHOCKING FEELING HE COULDN'T CONTROL HIS MUSCLES AND HE COULDN'T TALK. IT WAS REPORTED THAT THE PATIENT FELT SHOCKING WITH IS OLD INS (SEE MFR. REPORT # 3004209178-2012-12218) BUT IT HAD BEEN WORSE WITH THE NEW DEVICE. THE REPORTER STATED THAT THE SHOCKING WAS IN THE PATIENT'S SHOULDER AND RIGHT ARM AND UP INTO HIS HEAD. IT WAS NOTED THAT THE PATIENT KEPT THE DEVICE ON AT NIGHT AND SOMETIMES IT WOKE HIM UP DURING THE NIGHT. THE REPORTER STATED THAT THE NIGHT BEFORE THE REPORT IT WAS "REALLY BAD" AND THE PATIENT TRIED TO MAKE A CLOSED FIST AND COULDN'T CONTROL IT AND TRIED TO TALK AND ALL HE COULD DO WAS MUMBLE. IT WAS NOTED THAT THE PATIENT ONLY HAD IT ON ONE SIDE. THIS LIKELY MEANT THAT THE SHOCKING AND SYMPTOMS WERE ONLY AFFECTING ONE SIDE OF THE PATIENT. IT WAS REPORTED THAT BEFORE THE PATIENT GOT THE NEW DEVICE, AN X-RAY WAS DONE OF THE PATIENT'S HEAD TO MAKE SURE ALL OF THE CONNECTIONS WERE GOOD. IT WAS NOTED THAT THE PATIENT FELT LIKE HE "LOST CONTROL OF HIMSELF." IT WAS NOTED THAT THE PATIENT HAD CONTACTED HIS DOCTOR BUT HADN'T RECEIVED A RESPONSE AT THE TIME OF THE REPORT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT FELT AS IF THEY ¿HAD A HAT ON WHICH AT TIMES BECAME TIGHT.¿ THE PATIENT REPORTED THE SHOCKS THAT OCCURRED IN (B)(6) 2013 WERE ¿FULL FORCE¿ AND ¿MORE SEVERE¿ THAN THOSE THAT HE RECEIVED WITH HIS PREVIOUS INS. THE PATIENT STATED AT THE TIME OF REPORT THAT THEY ONLY USED THE INS ¿AT VERY SHORT INTERVALS DURING THE DAY.¿ IT WAS REPORTED THAT THE PATIENT¿S ¿RIGHT SIDE DID NOT FUNCTION CORRECTLY WHILE USING IT¿ AND ¿TURNED IT OFF TO EAT.¿ THE PATIENT FURTHER REPORTED THE ¿SHOCKS HAD BEEN SO SEVERE THAT THEY WERE COMPLETELY IMMOBILE AND COULD NOT SPEAK.¿ THE PATIENT NOTED THEY EXPERIENCED A SHOCK WHILE EXERCISING WITH THEIR THERAPIST. IT WAS REPORTED THAT WHEN ¿IN THAT STATED THEY NEEDED ASSISTANCE TO TURN THE IMPLANT OFF¿ AND THAT THE IMPLANT WAS ¿ALMOST USELESS.¿ THE PATIENT STATED THEY FELT ¿IN GRAVE DANGER.¿ ADDITIONAL INFORMATION STATED THE PATIENT EXPERIENCED ¿SHOCKING FEELINGS DOWN THE RIGHT SIDE OF HIS BODY¿ AND ¿JOLTING¿ SENSATIONS. IT WAS NOTED THE JOLTING ¿SEEMED TO BE RELATED TO POSITIONAL CHANGES¿ AND THAT THEY ¿GOT MORE INTENSE WITH MOVEMENT.¿ IT WAS REPORTED THE PATIENT WAS ¿VERY UNCOMFORTABLE THROUGHOUT THEIR FACE, RIGHT ARM, AND LEG.¿ IT WAS NOTED THERE WAS ¿NO SHOCKING ALONG THE INS/EXTENSION/LEAD PATH¿ AND THAT ¿PALPATION DID NOT ELICIT ISSUES.¿ THE PATIENT WAS NOTED TO HAVE BEEN REPROGRAMMED. IMPEDANCE VALUES WERE REPORTED AS ¿IN THE 3-4K RANGE.¿ X-RAY RESULTS ¿DID NOT SHOW AN ISSUE.¿ IT WAS NOTED THAT THE SHOCKING HAD RESOLVED ITSELF FOR A ¿WHILE¿ AFTER THE INS WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    149099 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1