BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACTIVA

    MDR report key: 4572818 · Received March 5, 2015

    Report

    Report Number
    3004209178-2015-04221
    Event Type
    Malfunction
    Date Received
    March 5, 2015
    Date of Event
    February 1, 2015
    Report Date
    February 13, 2015
    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
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3708660 SERIAL #: (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID 3708660, SERIAL #: (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: EXTENSION. PRODUCT ID 3387S-40, LOT# V030671, IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID 3387S-40, LOT# V012262, SERIAL#: (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE: LEAD. PRODUCT ID 7436, SERIAL#: (B)(4), PRODUCT TYPE: PROGRAMMER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEALTHCARE PROVIDER (HCP) WAS NOT ABLE TO ADJUST STIMULATION. A ¿CALL YOUR DOCTOR¿ ICON AND OUT OF REGULATION (OOR) CONDITION WERE DISPLAYED. THE PATIENT REPORTED A ¿SPACEY¿ SENSATION AND NECK TIGHTNESS AROUND (B)(6) 2015. WHEN THE SYMPTOMS OCCURRED, THEY COULD LAST A WHILE OR ALL DAY AND WERE CONSIDERED A LOSS OF EFFICACY. HE CALLED THE HCP ON (B)(6) 2015 AND THERE WAS NO OOR AT THAT TIME. THE OOR STARTED BETWEEN (B)(6) 2015. THE HCP STATED THAT WHEN THE PATIENT ADJUSTED HIS IMPLANTABLE NEUROSTIMULATOR (INS) ON THE RIGHT SIDE THE SENSATION WENT AWAY, BUT DID NOT IMPROVE WHEN THE LEFT SIDE WAS ADJUSTED. A SHORT WAS SUSPECTED, BUT IMPEDANCE MEASUREMENTS WITH HIM IN MULTIPLE POSITONS SHOWED THE RIGHT SIDE WAS ALL WITHIN RANGE AND THERE WERE NO ABNORMALITIES. THE HCP WOULD ATTEMPT TO REPROGRAM THE PATIENT TO A DIFFERENT ELECTRODE CONFIGURATION. THE HCP LATER REPORTED THAT THERE WAS SOME CONFUSION BETWEEN THE RIGHT SIDE AND LEFT SIDE. THE ACTUAL ISSUE WAS ON THE LEFT SIDE, WHICH AFFECTED THE PATIENT¿S RIGHT SIDE. THE AFFECTED SHORT WAS ON THE 0 THROUGH 3 ELECTRODES AND THE HCP SUSPECTED ELECTRODES 1 AND 2 MAY BE SHORTED DUE TO SIMILAR IMPEDANCES; CASE AND 1 WAS 969 OHMS AND CASE AND 2 WAS 924 OHMS. THE HCP WOULD CONTINUE TO RE-PROGRAM THE PATIENT. NO INTERVENTIONS OR PATIENT OUTCOME WERE REPORTED, SO ADDITIONAL INFORMATION WAS REQUESTED. IF ADDITIONAL INFORMATION IS RECEIVED A SUPPLEMENTAL REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT EXPERIENCED A ¿SPACY SENSATION¿ AND TIGHTNESS IN HIS NECK STARTING AROUND (B)(6) 2015. THE SENSATION WAS CONSTANT, BUT WOULD FLUCTUATE IN INTENSITY; IT WAS PRESENT AT REST AND WITH ACTIVITY. HE TURNED THE IMPLANTABLE NEUROSTIMULATOR (INS) OFF AND THE SENSATION ABATED. HOWEVER, WHEN HE TURNED THE INS BACK ON THE SENSATION RETURNED. THE PATIENT THEN DECREASED THE RIGHT SIDE VOLTAGE AND THERE WAS AN EXPECTED INCREASE IN TREMOR, BUT THE ¿SPACY SENSATION¿ REMAINED. WHEN THE LEFT SIDE VOLTAGE WAS DECREASED FROM 2.9 VOLTS TO 1.9 VOLTS, THE ¿SPACY SENSATION¿ AND NECK TIGHTNESS ABATED. ON (B)(6) 2015 THE PATIENT CHECKED HIS INS AND RECEIVED AN OUT OF REGULATION (OOR) WARNING INDICATION AND COULD NOT ADJUST STIMULATION. THE IMPEDANCES WERE ALL NORMAL, EVEN WITH THE PATIENT IN DIFFERENT POSITIONS AND WHEN PRESSURE WAS APPLIED. THE PATIENT WAS REPROGRAMMED WITH NO SIDE EFFECT, BUT WAS UNABLE TO ACHIEVE THE PREVIOUS LEVEL OF BENEFIT. ON GROUP A THE ¿SPACY SENSATION¿ ABATED, BUT HIS TREMOR WAS NOT CONTROLLED EVEN WITH THE VOLTAGE UP TO 3.9 VOLTS. ON GROUP B, THE ¿SPACY SENSATION¿ WAS SLIGHTLY PRESENT, BUT HIS TREMOR WAS NOT CONTROLLED EVEN WITH THE VOLTAGE UP TO 3.9 VOLTS. GROUP C WAS HIS PREVIOUS SETTING THAT HE USED 100% OF THE TIME AND PRIOR TO THE SENSATION WAS GOOD WITHOUT DIFFICULTY. HOWEVER, THERE WAS A POSSIBLE SHORT CIRCUIT ON THIS GROUP. ON GROUP D THE ¿SPACY SENSATION¿ WAS ABATED, BUT HIS TREMOR WAS NOT CONTROLLED EVEN WITH THE VOLTAGE UP TO 3.6 VOLTS. THE PATIENT WAS COMING BACK TO THE CLINIC ON (B)(6) 2015 FOR FURTHER EVALUATION.

    Description of Event or Problem · 1

    FOLLOW-UP RECEIVED FROM THE HEALTHCARE PROVIDER (HCP) REPORTED THAT REPROGRAMMING WAS PERFORMED. THE PATIENT¿S SYMPTOMS WERE STILL OCCURRING AS OF (B)(6) 2015. THREE OF THE FOUR GROUPS CAUSED UNCOMFORTABLE SENSATIONS THAT WERE PRESENT MOST OF THE TIME. ONE OF THE FOUR GROUPS DID NOT CAUSE THE SENSATION, BUT TREMOR WAS PRESENT. HE HAD OPTED TO KEEP THE THERAPY OFF FOR 90% OF THE TIME AND TURN IT ON JUST WHEN TREMOR CONTROL WAS ABSOLUTELY NEEDED. HIS ISSUES WERE CONSISTENT WITH A SHORT CIRCUIT, BUT TESTING OF THE HARDWARE SHOWED NORMAL IMPEDANCES AT HIS LAST VISIT. THE HCP WAS STILL WORKING WITH THE PATIENT TO REPROGRAM AND HE WOULD BE SEEN ON THE DAY OF THE REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER REPRESENTATIVE (REP) SAW THE PATIENT ON (B)(6) 2015. THE ELECTRICAL IMPEDANCES SHOWED THAT THERE WAS A SHORT CIRCUIT IN CONTACT 1; THE EXACT NUMBER WAS NOT KNOWN, BUT IT WAS UNDER 250 OHMS. THE IMPEDANCES WERE NORMAL BEFORE THEN AND THE DEVICE WAS STILL SHOWING OUT OF REGULATION (OOR). HOWEVER, THE PATIENT WAS ABLE TO GET GOOD BENEFIT OFF OF OTHER AVAILABLE CONTACTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153909 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37601

    Patients

    Seq Age Sex Outcome Treatment
    1 00068 YR