BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KINETRA

    MDR report key: 3988161 · Received August 7, 2014

    Report

    Report Number
    3007566237-2014-02217
    Event Type
    Injury
    Date Received
    August 7, 2014
    Report Date
    July 15, 2014
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AGE AT TIME OF EVENT: THIS VALUE IS THE AVERAGE AGE OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. SEX:. THIS VALUE REFLECTS THE GENDER OF THE MAJORITY OF THE PATIENTS REPORTED IN THE ARTICLE AS SPECIFIC PATIENTS COULD NOT BE IDENTIFIED. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CORRESPONDENCE HAS BEEN SENT TO THE AUTHOR OF THE ARTICLE INQUIRING ABOUT INDIVIDUAL PATIENT INFORMATION AND ADDITIONAL INFORMATION REGARDING THE REPORTED EVENTS. THE DEVICE WAS USED FOR AN OFF LABEL INDICATION. THE DEVICE WAS USED TO TREAT TREMOR RESULTING FROM ACQUIRED BRAIN INJURY. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID NEU_INS_STIMULATOR, LOT# UNKNOWN, PRODUCT TYPE: IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3387, LOT# UNKNOWN, PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    SITSAPESAN, H.A., HOLLAND, P., OLIPHANT, Z., DE PENNINGTON, N., BRITTAIN, J.S., JENKINSON, N., JOINT, C., AZIZ, T.Z., GREEN, A.L. DEEP BRAIN STIMULATION FOR TREMOR RESULTING FROM ACQUIRED BRAIN INJURY. JOURNAL OF NEUROLOGY, NEUROSURGERY, AND PSYCHIATRY. 2014;85(7):811-815. DOI:10.1136/JNNP-2013-305340. SUMMARY: TO EVALUATE THE EFFICACY OF DEEP BRAIN STIMULATION (DBS) IN THE TREATMENT OF TREMOR RESULTING FROM ACQUIRED BRAIN INJURY (ABI). A SERIES OF EIGHT CONSECUTIVE PATIENTS WITH POST-ABI TREMOR WERE TREATED WITH DBS OF THE VENTROORALIS POSTERIOR (VOP)/ZONA INCERTA (ZI) REGION, AND SUBSEQUENTLY UNDERWENT BLINDED ASSESSMENTS USING BAIN'S TREMOR SEVERITY SCALE. VOP/ZI DBS PRODUCED A MEAN REDUCTION IN TREMOR SEVERITY OF 80.75% BASED ON BAIN'S TREMOR SEVERITY SCALE, WITH SIGNIFICANT REDUCTIONS IN ALL FIVE COMPONENT TREMOR SUBSCORES: REST, POSTURAL, KINETIC, PROXIMAL AND DISTAL. NO ADVERSE NEUROLOGICAL COMPLICATIONS WERE REPORTED, ALTHOUGH ONE PATIENT EXPERIENCED EXACERBATION OF PRE-EXISTING GAIT ATAXIA. VOP/ZI STIMULATION IS DEMONSTRATED HERE TO BE AN EFFECTIVE AND SAFE APPROACH FOR THE TREATMENT OF POST-ABI TREMOR IN THE LARGEST SERIES PUBLISHED AT THE TIME OF WRITING. REPORTED EVENT: 1. ONE PATIENT EXPERIENCED TWO INFECTIONS AT THE IMPLANTABLE NEUROSTIMULATOR (INS) SITE, RESULTING IN REPOSITIONING OF THE INS WITH NO FURTHER COMPLICATIONS. 2. ONE PATIENT EXPERIENCED AN IMPLANTABLE NEUROSTIMULATOR (INS) FAILURE, RESULTING IN RAPID TREMOR RECURRENCE, WHICH WAS ABOLISHED UPON INS REPLACEMENT. THE SOURCE LITERATURE INCLUDED THE FOLLOWING DEVICE SPECIFICS: LEAD MODEL 3387 IN ALL 8 PATIENTS; IMPLANTABLE NEUROSTIMULATOR KINETRA MODEL 7428 IN AT LEAST ONE PATIENT, UNKNOWN IMPLANTABLE NEUROSTIMULATOR IN REMAINING PATIENTS. 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
    464056 KINETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 7428 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 00037 YR Required Intervention