BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3130361 · Received May 24, 2013

    Report

    Report Number
    3007566237-2013-01743
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    February 6, 2013
    Report Date
    May 10, 2013
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    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. PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD MILD CONFUSION IN THE DAYS FOLLOWING LEAD IMPLANTATION.

    Description of Event or Problem · 1

    SHIH, L. C., VANDERHORST, V. G., LOZANO, A. M., HAMANI, C., MORO, E. IMPROVEMENT OF PISA SYNDROME WITH CONTRALATERAL PEDUNCULOPONTINE STIMULATION. MOVEMENT DISORDERS. 2013;28(4):555-556. DOI: 10.1002/MDS.25301. SUMMARY: A (B)(6) WOMAN WITH A HISTORY OF PARKINSON¿S DISEASE WAS REFERRED FOR PPN DBS SURGERY. FALLS, POSTURE AND GAIT WERE OBSERVED. THE PATIENT SHOWED OVERALL IMPROVEMENT IN PISA SYNDROME. REPORTED EVENT: A (B)(6) WOMAN EXPERIENCED MILD POSTOPERATIVE ENCEPHALOPATHY AND WORD-FINDING DIFFICULTY, FROM WHICH SHE RECOVERED WITHIN 2 WEEKS. AT 14 MONTHS OF FOLLOW-UP, DEMONSTRATED PROGRESSIVE IMPROVEMENT OF HER ASYMMETRIC BRADYKINETIC GAIT AND RIGHT AXIAL LEAN. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED. SEE ATTACHED LITERATURE ARTICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231185 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC NEUROMODULATION 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00062 YR Other