BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4102298 · Received September 19, 2014

    Report

    Report Number
    3004209178-2014-17382
    Event Type
    Injury
    Date Received
    September 19, 2014
    Report Date
    October 18, 2017
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE IMPLANTABLE NEUROSTIMULATOR (INS) (S/N (B)(4) FOUND NO SIGNIFICANT ANOMALY. THE INS WAS FUNCTIONALLY OKAY AND THERE WERE INSIGNIFICANT ANOMALIES.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3389S-40, LOT# VA0A6SN, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3389S-40, LOT# VA0AB21, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 37642, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3708660, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37603, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE DOCTOR THAT THE PATIENT MAY HAVE A SYSTEM MALFUNCTION AS THE LEFT SIDE OF HIS BODY DEVELOPED A TONIC CONTRACTION THAT LASTED 30 SECONDS WHEN THE RIGHT IMPLANTABLE NEUROSTIMULATOR (INS) WAS TURNED OFF. THE PATIENT WAS SEEN ON (B)(6) 2014 BY THE DOCTOR AND MANUFACTURER REPRESENTATIVE TO HAVE THE SYSTEM EVALUATED. THE PATIENT STATED THAT HE HAD MINIMAL EFFICACY SINCE (B)(6) 2013 AND WHAT LITTLE EFFICACY HE DID NOTICED HAD DECREASED RECENTLY. HE WAS HAVING MORE SPEECH AND TREMOR PROBLEMS. SINCE THAT DATE THE PATIENT HAD NOTICED THE TONIC CONTRACTION ON THE LEFT SIDE OF HIS FACE AND NECK AT THE MOMENT THE INS TURNED OFF. THE CONTRACTION WAS INTENSE FOR SEVERAL SECONDS AND HE FELT NUMBNESS IN HIS TONGUE. THE CONTRACTION FADED AWAY AFTER TEN TO FIFTEEN MINUTES. THE CONFIGURATION WAS CHANGED MULTIPLE TIMES AND THE CONTRACTION WAS LESS SEVERE. THE PATIENT WAS NOT TOLD WHEN THE INS WAS TURNED OFF IN ORDER TO RULE OUT THE INFLUENCE. IT WAS DISCOVERED THAT IF THE SETTINGS WERE SLOWLY DECREASED HE FELT INCREASED PARASTHESIAS IN HIS THUMB AND FINGERTIPS, BUT HE DID NOT HAVE THE FACE AND ARM TONIC CONTRACTION. IMPEDANCES WERE TAKEN IN SEVERAL POSITIONS AND WHILE PALPATING. THE IMPEDANCES WERE CONSISTENT THROUGHOUT AND WITHIN NORMAL RANGE. IT WAS NOTED THAT THE PLACEMENT OF THE LEAD WAS ¿TEXTBOOK¿ AND THERE WERE NO HISTORICAL IMPEDANCE VALUES AVAILABLE. THE PATIENT HAD REPROGRAMMING ONCE A MONTH TO ADDRESS THE EFFICACY ISSUES. IT WAS EVENTUALLY DECIDED THAT THE PATIENT WOULD HAVE HIS RIGHT INS AND EXTENSION REPLACED ON (B)(6) 2014. THE SURGERY HAD NOT YET OCCURRED, SO THE PATIENT OUTCOME WAS UNAVAILABLE. ADDITIONAL INFORMATION WILL BE REQUESTED AFTER THE REPORTED SURGICAL DATE AND IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THE MANUFACTURER REPRESENTATIVE SPOKE TO THE PATIENT ON (B)(6) 2014. THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS CHANGED OUT AND THE DOCTOR DECIDED THAT AN INS REPLACEMENT WAS A GOOD PLACE TO START BECAUSE IT WAS LEAST INVASIVE. IT WAS NOTED THE DOCTOR ALSO HAD A THEORY THAT THE INS WAS POTENTIALLY MALFUNCTIONING AND SENDING OUT EXTRA STIMULATION WHEN TURNED OFF. THE PATIENT RECOVERED WELL AND WHEN THE INS WAS TURNED ON, 90% OF THE DISTAL TREMOR WAS CONTROLLED, 100% OF THE RESTING TREMOR WAS CONTROLLED, AND 85% OF THE PROXIMAL TREMOR WAS CONTROLLED. WHEN THE INS WAS TURNED OFF, THERE WAS STILL A SMALL CONTRACTION, BUT IT WAS ONLY ABOUT 20% AS STRONG AS IT HAD BEEN WITH THE PREVIOUS INS. TWO DAYS LATER THE PATIENT WAS STILL GETTING GOOD THERAPY, BUT THE FULL FORCE OF THE CONTRACTION WHEN THE STIMULATION WAS TURNED OFF WAS PRESENT AGAIN. ONE OF THE CONTRACTIONS THAT OCCURRED AFTER THE INS WAS TURNED OFF WAS SO STRONG SOME OF THE FILLINGS CAME OUT OF THE PATIENT'S TEETH. IT WAS UNCLEAR WHETHER THIS WAS DUE TO BITING DOWN DURING CONTRACTION OR DUE TO ANOTHER IMPETUS. THE PATIENT WAS GOING TO SEE THEIR HEATH CARE PROVIDER ON (B)(6) 2014 FOR ANOTHER APPOINTMENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED. IT WAS REPORTED THE PREVIOUS INS WAS DEFECTIVE AND REPLACING IT RESOLVED THE REPORTED ISSUES. NO FURTHER COMPLICATIONS WERE REPORTED OR ARE ANTICIPATED..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584100 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37603

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention