BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 3955904 · Received July 24, 2014

    Report

    Report Number
    3004209178-2014-13496
    Event Type
    Injury
    Date Received
    July 24, 2014
    Report Date
    July 7, 2014
    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
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3387S-40, LOT # V846962, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 3387S-40, LOT # V865889, IMPLANTED: (B)(6) 2012, PRODUCT TYPE LEAD; PRODUCT ID 37085-60, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 37085-40, SERIAL # (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2012, PRODUCT TYPE EXTENSION; PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED ON (B)(6) 2012 THAT THE PATIENT HAD ACUTE PAIN AND WHEN SHE MOVED HER NECK IT WAS PAINFUL. THERE WAS ALSO A TIGHT FEELING WHERE THE LEAD, EXTENSION, AND IMPLANTABLE NEUROSTIMULATOR (INS) WERE LOCATED. THE PATIENT STATED THAT ONE COULD SEE THE INS MOVE WHEN SHE MOVED HER HEAD. THE PATIENT NOTED THAT THIS FEELING BEGAN APPROXIMATELY TWO TO THREE WEEKS POST IMPLANT. THE PATIENT SAW HER MANUFACTURER REPRESENTATIVE IN (B)(6) 2012 TO TURN OFF HER INS FOR EYE SURGERY AND DISCUSSED THE ISSUE WITH THEM AND BOTH OF HER DOCTORS, BUT NOTHING WAS BEING DONE ABOUT IT. EIGHT DAYS LATER, IT WAS REPORTED THAT THE PATIENT HAD ¿RESTRICTED NECK MOVEMENT¿ AND PULLING OF THE INS AT THE INS SITE SINCE IMPLANT. THE PATIENT ALSO REPORTED THAT ¿BEHIND THE BATTERY PACK, SHE FELT A BURNING MISERABLE PAIN, WHICH WAS ABOUT A 5-6 ON PAIN SCALE.¿ THE PATIENT NOTED THAT THE ISSUES STARTED THREE TO FOUR WEEKS POST IMPLANT OF THE INS. THE ISSUES WERE AT THE INS LOCATION, THE RIGHT UPPER CHEST, THE LEAD-EXTENSION CONNECTION LOCATION, AND THE EXTENSION LOCATION. THE PATIENT¿S STATUS WAS FAIR, BUT SHE WAS VERY FRUSTRATED WITH HER HEALTHCARE PROVIDER (HCP) AS SHE HAD BEEN PUSHED OFF BY THE HCP. THE PATIENT WAS SUPPOSED TO BE GETTING A CALLBACK FROM THE SURGEON OR NURSE ON THE DAY OF THE REPORT TO DISCUSS FURTHER OPTIONS. THE PATIENT DISCUSSED AN X-RAY WITH THE SURGEON IN (B)(6) , BUT WAS TOLD THAT ¿X-RAYS WOULD NOT ALLOW THEM TO SEE THE EXTENSION.¿ THE PATIENT MENTIONED THAT BEING UNABLE TO TURN HER HEAD MADE IT CHALLENGING TO DO THINGS. ABOUT TWO WEEKS LATER, IT WAS REPORTED THAT THE PATIENT WAS STILL HAVING CONCERNS REGARDING HER DEVICE OR THERAPY, BUT WAS WORKING WITH HER DOCTOR OR MANUFACTURER REPRESENTATIVE. ABOUT TWO MONTHS LATER, IT WAS REPORTED THAT THE PATIENT HAD AN ISSUE WITH SCAR TISSUE RESTRICTING THE LEAD FROM HER THERAPY TO THE BATTERY PACK. IT PULLED WHEN THE PATIENT MOVED HER HEAD AND PULLED THE BATTERY PACK, WHICH WAS PAINFUL. THE DOCTOR STATED THAT HE COULD DO SURGERY TO RELEASE THE SCAR TISSUE, BUT COULD NOT PREVENT IT FROM HAPPENING AGAIN. A DIFFERENT DOCTOR WAS WILLING TO SEE THE PATIENT AND TRY TO RELEASE THE SCAR TISSUE AND FELT HE COULD DO A PROCEDURE WHICH MAY BE ABLE TO PREVENT THE SCAR TISSUE PROBLEM FROM HAPPENING AGAIN. THE FIRST DOCTOR RECOMMENDED ASTYM THERAPY, WHICH THE PATIENT DID TWICE A WEEK FOR SEVEN WEEKS, BUT IT WAS NOT EFFECTIVE AND ¿SURE DID HURT.¿ THE PATIENT NOTED THAT THE THERAPY HAD BEEN WONDERFUL FOR HER TREMORS WHICH WERE ABOUT 99% CORRECTED. THE PATIENT¿S LEGS SHAKING AND HEAD NODDING WERE ALSO GONE. THE PATIENT MENTIONED THAT SHE HAD TWO SURGERIES, ONE ON EACH SIDE. THE PATIENT HAD THE LEADS GOING INTO A LARGER BATTERY, RATHER THAN TWO SMALLER ONES. IT FELT AS THOUGH THE SIDES, CORNERS, AND EDGES FELT KIND OF SHARP, SO IT WAS NOTICEABLY UNCOMFORTABLE. THE PATIENT SUGGESTED THAT IF THE INS COULD BE DESIGNED WITH THE TYPE OF CONTOURS AS THE REMOTE, IT WOULD BE SMOOTHER AND PROBABLY MORE COMFORTABLE. THE PATIENT SUGGESTED THAT MAYBE SHE JUST HAD NOT HAD IT IN HER BODY LONG ENOUGH TO GET USED TO IT. ABOUT TWO WEEKS LATER, IT WAS REPORTED THAT THE CAUSE OF THE EVENT WAS TIGHTNESS OF THE EXTENSION CABLE WITH HEAD TURNING. THE EVENT WAS ATTRIBUTED TO THE EXTENSION. NO PROGRAMMING OR INTERVENTION WAS PERFORMED. NO HOSPITALIZATION WAS REQUIRED AND THE PATIENT OUTCOME WAS NOTED AS NO INJURY. ALMOST TWO YEARS LATER IT WAS REPORTED THAT THE PATIENT¿S FIRST DOCTOR ¿KIND OF SCREWED THINGS UP WHEN SHE HAD THE IMPLANT IN 2012.¿ THE PATIENT STATED THAT IT TOOK TWO SURGERIES TO CORRECT THINGS. THE PATIENT DID NOT KNOW WHY, BUT FROM THE TIME THE BATTERY PACK WAS INSTALLED HER HEAD WAS SO RESTRICTED THAT IF SHE MOVED HER HEAD AT ALL IT WAS PULLING THAT BATTERY PACK AND SHE COULD FEEL IT TEARING TISSUE. THE PATIENT STATED THAT SHE CALLED HER FIRST DOCTOR¿S OFFICE ¿DAY AFTER DAY STARTING RIGHT AFTER THE SURGERY IN (B)(6), BUT NEVER GOT A CALL BACK.¿ THE ONLY TIME THE PATIENT SPOKE WITH THE FIRST DOCTOR WAS AT THE POST-OPERATIVE VISIT AND ¿SHE WAS ALREADY A WEEK IN FRUSTRATION, BUT SHE JUST HAD SURGERY SO SHE DID NOT KNOW WHAT SHOULD BE RIGHT OR WRONG, BUT FELT LIKE HER HEAD SHOULD NOT BE SO RESTRICTED.¿ IN (B)(6) 2012, THE PATIENT SAW A NEW DOCTOR AND THE FIRST THING HE DID WAS ORDER X-RAYS. THE DOCTOR STATED THAT THE X-RAY DID NOT LOOK GOOD AND REPLACED THE EXTENSION THAT WAS NINE INCHES LONGER BECAUSE THE OTHER WAS TOO SHORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433814 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention