BEUDAMED
    FDA Adverse Event Death Summary report: N

    ACTIVA

    MDR report key: 4147772 · Received October 7, 2014

    Report

    Report Number
    3007566237-2014-02867
    Event Type
    Death
    Date Received
    October 7, 2014
    Report Date
    September 9, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. DATE OF DEATH WAS NOT GIVEN; DATE ARTICLE WAS RECEIVED WAS USED AS IT WAS THE EARLIEST DATE KNOWN. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 7426, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 37651, LOT# UNKNOWN, PRODUCT TYPE: RECHARGER; PRODUCT ID 37612, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 7426, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 7426, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 7426, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 37612, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD; PRODUCT ID 37612, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR. (B)(4).

    Description of Event or Problem · 1

    WALN, O., JIMENEZ-SHAHED, J. RECHARGEABLE DEEP BRAIN STIMULATION IMPLANTABLE PULSE GENERATORS IN MOVEMENT DISORDERS: PATIENT SATISFACTION AND CONVERSION PARAMETERS. NEUROMODULATION : JOURNAL OF THE INTERNATIONAL NEUROMODULATION SOCIETY. 2014;17(5):425-430. DOI: 1 0.1111/NER.12115. SUMMARY: RECHARGEABLE (RC) IMPLANTABLE PULSE GENERATORS (IPGS) FOR DEEP BRAIN STIMULATION (DBS) IN MOVEMENT DISORDERS HAVE RECENTLY BECOME AVAILABLE. NO GUIDELINES EXIST FOR PARAMETER ADJUSTMENT AFTER CONVERSION OF NON-RC TO RC IPGS, OR REPORTS OF PATIENT SATISFACTION WITH RC IPGS WHEN USED AS INITIAL DBS DEVICE OR AFTER CONVERSION FROM NON-RC IPGS. PATIENTS WHO UNDERWENT PLACEMENT OF ACTIVA RC IPG (MEDTRONIC, INC.) WERE SURVEYED BY PHONE ABOUT DEVICE SATISFACTION. THEIR CHARTS WERE RETROSPECTIVELY REVIEWED AND DBS SETTINGS WERE ANALYZED. THE STIMULATION SETTINGS BEFORE AND AFTER CONVERSION TO RC WERE COMPARED. THIRTY-ONE PATIENTS (AGE 15¿90; 18 MALE) WITH MOVEMENT DISORDERS (NINE PARKINSON¿S DISEASE, NINE DYSTONIA, EIGHT ESSENTIAL TREMOR, FIVE OTHERS) WERE IDENTIFIED. TWELVE SUBJECTS HAD INITIAL RC IPG IMPLANTATION; 19 WERE CONVERTED FROM NON-RC IPGS (SOLETRA; MEDTRONIC, INC.) 2¿14 YEARS AFTER INITIAL DBS IMPLANT (MEAN 6.3 ± 3.44 YEARS). TWENTY-SIX PATIENTS (17 CONVERSIONS) WERE SURVEYED AN AVERAGE OF 12.1 MONTHS SINCE RC IPG IMPLANTATION. OVERALL SATISFACTION WITH RC WAS HIGH. PATIENTS CONVERTED TO RC WERE MORE LIKELY TO CHOOSE IT AGAIN THAN THOSE WITH INITIAL RC. PATIENTS DENIED DIFFERENCES IN SYMPTOM CONTROL AFTER CONVERSION. MEAN AMPLITUDE, PULSE WIDTH, AND FREQUENCY WERE SLIGHTLY LOWER AFTER CONVERSION REGARDLESS OF DIAGNOSIS AND REMAINED LOWER AFTER THREE POST CONVERSION REPROGRAMMING WITH SLOW DRIFT OF AMPLITUDE BACK TO PRE CONVERSION SETTINGS, MORE IN THE GPI GROUP. RC IPGS IN DBS FOR MOVEMENT DISORDERS ARE WELL RECEIVED BY PATIENTS AS INITIAL THERAPY AND AFTER CONVERSION. MILD REDUCTION IN STIMULATION PARAMETERS MIGHT BE ALLOWED AFTER CONVERSION TO RC IPG. REPORTED EVENTS: 1 PATIENT WITH PARKINSON¿S DISEASE DIED FROM ACUTE STROKE ONE MONTH AFTER IMPLANT. 1 PATIENT WITH PARKINSON¿S DISEASE HAD A DRAINED OR MALFUNCTIONING IMPLANTABLE NEUROSTIMULATOR PRIOR TO CONVERSION TO RECHARGEABLE UNIT. 1 PATIENT WITH ESSENTIAL TREMOR HAD A DRAINED OR MALFUNCTIONING IMPLANTABLE NEUROSTIMULATOR PRIOR TO CONVERSION TO RECHARGEABLE UNIT. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628214 ACTIVA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 37612 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death