BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4003036 · Received August 12, 2014

    Report

    Report Number
    3004209178-2014-15169
    Event Type
    Injury
    Date Received
    August 12, 2014
    Report Date
    July 23, 2014
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO.
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 3708695, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION; PRODUCT ID 3708695, SERIAL # (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE EXTENSION; PRODUCT ID 37642, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 3387S-40, LOT # VA0HYJM, IMPLANTED: (B)(6) 2014, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3708695, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID 3708695, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID 3387S-40, LOT# VA0HYJM, IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. PRODUCT ID 3708695, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. PRODUCT ID 3708695, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: EXTENSION. (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE IMPLANT HAD MOVED DUE TO WEIGHT LOSS OF ABOUT 40 POUNDS 6 WEEKS TO A MONTH PRIOR TO THE DATE OF THIS REPORT. AT ONE POINT IN TIME THEY HAD BEEN UNABLE TO FIND IT. THIS HAD EVIDENTIALLY PUT TENSION ON THE WIRES AND THE WIRES SHORTED OUT AND CAUSED PROBLEMS. THE SURGEON WAS GOING TO REPLACE THEM ONCE THE ISSUE WAS DETERMINED. THE INS WAS 4 INCHES BELOW WHERE IT WAS SUPPOSED TO BE WHICH IS WHY THEY COULD NOT FIND IT. THE PATIENT WAS EXPERIENCING ALLERGIC REACTION LIKE SYMPTOMS. THIS ISSUE HAD BEGUN ABOUT 2 WEEKS PRIOR TO THE DATE OF THIS REPORT. THERE WAS SWELLING AND REDNESS WHERE THE WIRE WENT INTO THE CHEST. IT WAS WHERE THE LEADS WERE, THE INS WAS ON THE LEFT SIDE, THERE WAS TWO SPOTS WHERE IT WAS INFLAMED. ONE INFLAMMATION SITE WAS HALFWAY BETWEEN THE COLLAR BONE AND NIPPLE, IT WAS ROUND IN SHAPE AND ABOUT 3 INCHES IN DIAMETER; THE SECOND INFLAMMATION SITE WAS HORIZONTAL IN SHAPE BELOW THE LEFT BREAST. THE PATIENT HAD NOT EVEN KNOWN THERE WAS A WIRE THERE UNTIL IT HAD BECOME SWOLLEN AND PAINFUL. IT HAD BEEN TESTED BY MULTIPLE HEALTHCARE PROFESSIONALS AND THERE HAD BEEN NO SIGN OF INFECTION BUT THEY HAD BEEN UNABLE TO FIGURE OUT WHAT WAS WRONG. THEY WERE NOT CONCERNED THAT IT WAS AN ALLERGIC REACTION EVEN THOUGH IT LOOKED LIKE IT. DURING THE FIRST WEEK OF THIS ISSUE IT HAD BEEN PAINFUL AND ITCHING. NO OUTCOME WAS PROVIDED REGARDING THE EVENT. FURTHER FOLLOW-UP IS BEING DONE TO OBTAIN THIS INFORMATION. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WENT IN TO THE HEALTHCARE PROVIDER (HCP) ON (B)(6) 2014 AND WAS SET ON A PROGRAM. THE PATIENT STAYED ON IT UNTIL THE FOLLOWING MORNING, BUT GOT TO WHERE HE WAS SLURRING HIS SPEECH AND ¿FEELING DRUNK.¿ THE PATIENT CHANGED THE STIMULATION THAT SAME MORNING, BUT WENT BACK TO THE PROGRAM ON (B)(6) 2014 AND COULD NOT GET OFF OF IT. THE PATIENT WENT IN TO THE HCP THAT SAME DAY FOR A CHANGE IN PROGRAMMING. THE FOLLOWING DAY THE PATIENT WENT BACK IN FOR MORE PROGRAMMING AND THAT WAS WHEN HIS IMPLANTABLE NEUROSTIMULATOR (INS) WAS DISCOVERED TO HAVE SHIFTED. THE PATIENT HAD LOST 35 POUNDS SINCE IMPLANT, WHICH HAD CAUSED THE SHIFT. WHETHER THE PATIENT STOOD, SAT, OR LIED DOWN THE INS WAS MOVING FOUR INCHES AWAY FROM WHERE IT STARTED AND THE SIGNAL WAS DIFFERENT. THE INS SEEMED TO HAVE SHIFTED INFERIOR AND LATERALLY. THE PATIENT WAS HAVING TROUBLE LOCATING HIS INS WITH HIS PROGRAMMER AND AFTER EXTENSIVE TRAINING HE WAS ABLE TO MAKE SOME ADJUSTMENTS. AT THE TIME OF THE VISIT THE PATIENT HAD ALSO EXPERIENCED WEAKNESS, TIREDNESS, BALANCE DIFFICULTY, TREMORS, JOINT AND NECK STIFFNESS, AND NECK PAIN. THE PATIENT BECAME ANXIOUS AND FATIGUED AFTER PROGRAMMING AND COMPLAINED OF MULTIPLE PARASTHESIAS WITH MINIMAL CHANGES TO THE THERAPY. THE IMPEDANCES WERE MEASURED AND ALL WITHIN NORMAL LIMITS. THE PATIENT WAS TO ADJUST STIMULATION ON HIS OWN AND NOTE ANY IMPROVEMENT. THE PATIENT NOTED OVERALL THAT HIS THERAPY HAD BEEN A ¿GODSEND¿ AND HE WOULD HAVE FOLLOW UP ONE WEEK AFTER THE REPORT. THE PATIENT OUTCOME WAS NOT REPORTED, SO ADDITIONAL INFORMATION WAS REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478143 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC PUERTO RICO OPERATIONS CO. 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR Required Intervention