BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3140760 · Received May 31, 2013

    Report

    Report Number
    3007566237-2013-01823
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    January 1, 2006
    Report Date
    August 23, 2011
    Manufacturer
    IPG MFG SWITZERLAND
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3387-28, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: LEAD; PRODUCT ID 7495-51, SERIAL# (B)(4), IMPLANTED: (B)(6) 2002, PRODUCT TYPE: EXTENSION. CORRECTION: MFG ID SHOULD BE 9614453. INFORMATION PERTAINING TO THIS EVENT IS ONLY INCLUDED; INFORMATION PERTAINING TO SEPARATE EVENTS HAVE BEEN REPORTED IN SEPARATE MANUFACTURING REPORTS.

    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. CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID NEU_UNKNOWN_LEAD, SERIAL# UNKNOWN. PRODUCT TYPE: LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE DEVICE HAD BEEN EXPLANTED. THERE WAS NO INFORMATION REGARDING THE REASON AS TO WHY THE DEVICE WAS EXPLANTED OR THE TIME FRAME OF THE EXPLANT.

    Description of Event or Problem · 1

    KADOWAKI, T., HASHIMOTO, K., SUZUKI, K., WATANABE, Y., HIRATA, K. CASE REPORT: RECURRENT PARKINSONISM-HYPERPYREXIA SYNDROME FOLLOWING DISCONTINUATION OF SUBTHALAMIC DEEP BRAIN STIMULATION. MOVEMENT DISORDERS. 2011;26(8):1561-1562. DOI: 10.1002/MDS.23596. SUMMARY/REPORTED EVENT: IT WAS REPORTED THAT THE PATIENT BECAME MANIC FOLLOWING BILATERAL STIMULATION. TWO YEARS AFTER SURGERY, THE PATIENT¿S MANIC SYMPTOMS BECAME MORE PROMINENT, AND HE WAS THEREFORE ADMITTED TO OUR HOSPITAL. THE DEVICES WERE TURNED OFF. ON THE THIRD DAY IN THE HOSPITAL, HIS MANIC SYMPTOMS DISAPPEARED; HOWEVER, HE BECAME SOMNOLENT AND COMPLETELY IMMOBILE WITH SEVERE RIGIDITY. HE WAS FEBRILE WITH A TEMPERATURE OF 38.7_C AND A PULSE RATE OF 120/MIN. LABORATORY TESTS REVEALED AN ELEVATED WHITE BLOOD CELL COUNT(12,600/LL) AND POSITIVE C-REACTIVE PROTEIN (1.03 MG/DL). SERUM CREATINE KINASE WAS ELEVATED TO 1878 U/L. PARKINSONISM-HYPERPYREXIA SYNDROME (PHS) WAS CONSIDERED, AND STANDARD INFUSION THERAPY WAS STARTED. ON DAY 6, HE WAS AFEBRILE WITH A NORMAL CONSCIOUSNESS LEVEL; DEEP BRAIN STIMULATION (DBS) WAS SWITCHED ON WITH THE SAME SETTINGS, RESULTING IN AN IMPROVEMENT IN RIGIDITY AND AKINESIA. ONE YEAR LATER, HIS MEDICATION WAS DISCONTINUED. THE PATIENT DEVELOPED A MANIC STATE IN (B)(6), (B)(6) 2008, AND (B)(6) 2009. BECAUSE APPLYING ANTIPSYCHOTICS OR CHANGING THE STIMULATING SITE OF THE DBS ELECTRODE DID NOT AMELIORATE HIS MANIC SYMPTOMS, DBS HAD TO BE DISCONTINUED IN EACH EPISODE, RESULTING IN THE RECURRENCE OF PHS. EACH INCIDENCE OF PHS WAS REVERSED BY STANDARD FLUID THERAPY, FOLLOWED BY REINTRODUCTION OF DBS. IN (B)(6) 2010, HE WAS HOSPITALIZED WITH A SIMILAR MANIC STATE. IT WAS STATED THAT LOW VOLTAGE STIMULATION (2.0 V, 90 LS, 145 HZ) WAS APPLIED WHICH PREVENTED THE DEVELOPMENT. FURTHER INFORMATION HAS BEEN REQUESTED; A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT BECAME MANIC FOLLOWING BILATERAL STIMULATION. TWO YEARS AFTER SURGERY, THE PATIENT¿S MANIC SYMPTOMS BECAME MORE PROMINENT, AND HE WAS THEREFORE ADMITTED TO OUR HOSPITAL. THE DEVICES WERE TURNED OFF. ON THE THIRD DAY IN THE HOSPITAL, HIS MANIC SYMPTOMS DISAPPEARED; HOWEVER,HE BECAME SOMNOLENT AND COMPLETELY IMMOBILE WITH SEVERE RIGIDITY. HE WAS FEBRILE WITH A TEMPERATURE OF 38.7_C AND A PULSE RATE OF 120/MIN. LABORATORY TESTS REVEALED AN ELEVATED WHITE BLOOD CELL COUNT (12,600/LL) AND POSITIVE C-REACTIVE PROTEIN (1.03 MG/DL). SERUMCREATINE KINASE WAS ELEVATED TO 1878 U/L. PARKINSONISM-HYPERPYREXIA SYNDROME (PHS) WAS CONSIDERED, AND STANDARD INFUSION THERAPY WAS STARTED. ON DAY 6, HE WAS AFEBRILE WITH A NORMAL CONSCIOUSNESS LEVEL; DEEP BRAIN STIMULATION (DBS) WAS SWITCHED ON WITH THE SAME SETTINGS, RESULTING IN AN IMPROVEMENT IN RIGIDITY AND AKINESIA. ONE YEAR LATER, HIS MEDICATION WAS DISCONTINUED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241630 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY IPG MFG SWITZERLAND 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 00060 YR Hospitalization| O