BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3397485 · Received October 9, 2013

    Report

    Report Number
    3004209178-2013-17757
    Event Type
    Injury
    Date Received
    October 9, 2013
    Date of Event
    July 17, 2008
    Report Date
    September 24, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MRU
    PMA / PMN Number
    H020007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE ACTUAL EVENT DATES WERE NOT PROVIDED. THIS DATE IS BASED ON THE DATE OF PUBLICATION OF THE ARTICLE. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFORMATION FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. CONCOMITANT: PRODUCT ID 7426 SERIAL# (B)(4) IMPLANTED: (B)(6) 2008 EXPLANTED: (B)(6) 2008 PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID 3387S-40 LOT# V106048 IMPLANTED: (B)(6) 2008 EXPLANTED: (B)(6) 2009 PRODUCT TYPE LEAD; PRODUCT ID 3387S-40 LOT# V106048 IMPLANTED: (B)(6) 2008- EXPLANTED: (B)(6) 2009 PRODUCT TYPE LEAD; PRODUCT ID NEU_UNKNOWN_EXT IMPLANTED: (B)(6) 2008 EXPLANTED: (B)(6) 2008 PRODUCT TYPE EXTENSION; PRODUCT ID NEU_UNKNOWN_EXT, IMPLANTED: (B)(6) 2008 EXPLANTED: (B)(6) 2008 PRODUCT TYPE EXTENSION. (B)(4).

    Description of Event or Problem · 1

    MARKS, W., BAILEY, L., REED, M., POMYKAL, A., MERCER, M., MACOMBER, D., ACOSTA, F., HONEYCUTT, J. PALLIDAL STIMULATION IN CHILDREN: COMPARISON BETWEEN CEREBRAL PALSY AND DYT1 DYSTONIA. JOURNAL OF CHILD NEUROLOGY. 2013;28(7):840-848. DOI:10.1177/0883073813488674 SUMMARY: THE AUTHORS COMPARED THE OUTCOMES OF 17 CHILDREN AGED 7 TO 15 YEARS WITH DYT1 DYSTONIA OR CEREBRAL PALSY FOLLOWING DEEP BRAIN STIMULATION. WHILE PATIENTS WITH CEREBRAL PALSY PRESENTED WITH SIGNIFICANTLY GREATER MOTOR DISABILITY THAN THE DYT1 COHORT AT BASELINE, BOTH GROUPS DEMONSTRATED IMPROVEMENT AT 1 YEAR (CEREBRAL PALSY ¼ 24%; DYT1 ¼ 6%). THE GROUP AS A WHOLE DEMONSTRATED SIGNIFICANT IMPROVEMENT ON THE BARRY-ALBRIGHT DYSTONIA SCALE ACROSS TIME. GAINS IN MOTOR FUNCTION WERE APPARENT IN BOTH AXIAL AND APPENDICULAR DISTRIBUTIONS INVOLVING BOTH UPPER AND LOWER EXTREMITIES. GAINS ACHIEVED BY 6 MONTHS WERE SUSTAINED IN THE CEREBRAL PALSY GROUP, WHEREAS THE DYT1 GROUP DEMONSTRATED CONTINUED IMPROVEMENT WITH ONGOING PALLIDAL STIMULATION BEYOND 18 MONTHS. YOUNG PATIENTS WITH DYSTONIA DUE TO CEREBRAL PALSY RESPONDED COMPARABLY TO PATIENTS WITH DYT1 DYSTONIA. THE SEVERITY OF MOTOR IMPAIRMENT IN PATIENTS WITH CEREBRAL PALSY AT BASELINE AND FOLLOW-UP RAISES THE ISSUE OF EVEN EARLIER INTERVENTION WITH NEUROMODULATION IN THIS POPULATION TO LIMIT LONG-TERM MOTOR IMPAIRMENTS DUE TO DYSTONIA. REPORTED EVENT: AN (B)(6) MALE PATIENT, WHO HAD A BILATERAL DBS IMPLANTED ON (B)(6)2008, DEVELOPED AN INFECTION EARLY IN THE PROGRAM. THE PATIENT HAD THE PULSE GENERATORS AND EXTENSIONS REMOVED AND AN INCISION AND DRAINAGE OF SCALP INCISIONS ON (B)(6) 2008. IT WAS NOTED THAT THE WOUND CULTURE GREW (B)(6). THIS EVENT WAS PREVIOUSLY REPORTED IN MANUFACTURING REPORT # 3007566237-2013-02622. ANY ADDITIONAL INFORMATION REGARDING THIS EVENT WILL BE REPORTED IN THE NEW MANUFACTURING REPORT #. PLEASE REFERENCE MANUFACTURING REPORT # 3004209178-2013-17756 FOR THE REPORT ON THE PATIENT'S OTHER IMPLANTABLE NEUROSTIMULATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    512595 SOLETRA IMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS) MRU MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00011 YR Required Intervention