BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACTIVA

    MDR report key: 4151139 · Received October 8, 2014

    Report

    Report Number
    3004209178-2014-18476
    Event Type
    Injury
    Date Received
    October 8, 2014
    Report Date
    September 16, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCLUSION CODE AND DEVICE CODE WAS NOT RELATED TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 37602, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. PRODUCT ID: 3387-40, LOT# L61921, IMPLANTED: (B)(6) 1999, PRODUCT TYPE: LEAD. PRODUCT ID: 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 1999, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3387-40, LOT# L68600, IMPLANTED: (B)(6) 1999, PRODUCT TYPE: LEAD. PRODUCT ID: 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 1999, PRODUCT TYPE: EXTENSION. PRODUCT ID: NEU_PTM_PROG, SERIAL# UNKNOWN, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE HEALTHCARE PROVIDER (HCP) TOLD THE PATIENT THE DAY PRIOR TO THE REPORT THAT ONE OF HIS IMPLANTABLE NEUROSTIMULATORS (INS) NEEDED TO BE REPLACED IMMEDIATELY. HE WANTED TO KNOW WHY IT ONLY LASTED FOR TWO AND A HALF YEARS AS OPPOSED TO HIS PREVIOUS INS. THE INS THAT NEEDED TO BE REPLACED RAN AT ABOUT 3.6 VOLTS, HAD THREE ACTIVE CONTACTS, AND A RELATIVELY HIGH PULSE WIDTH. THE OTHER INS ONLY USED TWO ELECTRODES, BUT THE PATIENT FELT LIKE IT WOULD GO OUT BEFORE THE NEW INS WAS PUT IN. THE PATIENT WAS SCHEDULED TO HAVE BOTH INS¿S REPLACED ON (B)(6) 2014. HE ALSO MENTIONED THAT HE DID NOT HAVE AS MUCH CONTROL ON THE LEFT SIDE OF HIS BODY UNLESS HE TURNED THE STIMULATION UP HIGHER THAN WHAT HE KEPT IT AT NORMALLY. HE STATED THAT HE DID NOT NEED AS MUCH CONTROL, SINCE HE WAS RIGHT HANDED, AND KEPT IT LOWER WHEN HE WAS NOT USING HIS LEFT HAND. THE PATIENT ALSO GOT PARALYSIS IN HIS TONGUE AND THROAT WHEN BOTH INS¿S WERE TURNED ON A HIGH SETTING. NO PATIENT OUTCOME WAS REPORTED AS THE INTERVENTION HAD NOT YET OCCURRED, SO ADDITIONAL INFORMATION WAS TO BE REQUESTED AFTER. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SENT. REFER TO MANUFACTURING REPORT #3004209178-2014-18475 AS THE PATIENT HAD TWO INS¿S IMPLANTED AND BOTH WERE INVOLVED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM A CONSUMER REPORTED THEIR IMPLANTABLE NEUROSTIMULATORS (INS) DID NOT LAST VERY LONG AND THEY NEEDED TO BE REPLACED. THE INSS ONLY LASTED TWO YEARS. THE PATIENT HAD THE SAME SETTINGS AS THEIR PRIOR INSS WITH NO CHANGES AND THOSE INSS LASTED 4-5 YEARS. THE PATIENT HAD AN APPOINTMENT TO HAVE THEIR INSS CHECKED EVERY MONTH. AT THE LAST APPOINTMENT, THE PATIENT WAS TOLD THE INSS NEEDED TO BE REPLACED SOON. THE PATIENT'S INDICATION FOR USE IS ESSENTIAL TREMOR.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD NOT DISCUSSED THE PARALYSIS OF THE TONGUE WITH THEIR HEALTHCARE PROFESSIONAL (HCP). THE HCP LAST SAW THE PATIENT ON (B)(6) 2014 AND EVERYTHING WAS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633424 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MDT PUERTO RICO OPERATIONS CO 37602

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R