BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 1667399 · Received April 23, 2010

    Report

    Report Number
    3004209178-2010-03331
    Event Type
    Injury
    Date Received
    April 23, 2010
    Date of Event
    November 1, 2009
    Report Date
    March 29, 2010
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO., JUNCOS
    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

    (B) (4)

    Description of Event or Problem · 1

    IT WAS REPORTED THE PT EXPERIENCED AMBULATION CHANGES, NAUSEA, DIZZINESS, NEW PAIN, LEFT SIDED TIGHTNESS, AND BLURRED VISION. THE SYMPTOMS OCCURRED ON THE LEFT SIDE. THIS OCCURRED TWICE WHEN THE PT WAS STRETCHING BACKWARD AND FORWARD. IMPEDANCE READINGS WERE NORMAL WITH THE PT STRETCHING. C0: 588 OHMS, C1: 858 OHMS, C2: 816 OHMS, C3: 1146 OHMS, 01: 864 OHMS, 02: 1020 OHMS, 03: 1397 OHMS, 12: 954 OHMS, 13: 1500 OHMS, 23: 1037 OHMS. THE 0+1-2- 5.8V/450PW/100HZ AND THERAPY IMPEDANCE OF 717 OHMS. THE BATTERY VOLTAGE WAS MEASURING AT 3.67V AND AT BOL BATTERY WAS 3.72V. THE PT WAS A DYSTONIA PT WITH HIGH ENERGY USAGE. THE HCP INDICATED A POSSIBLE EXTENSION FRACTURE BUT WAS UNABLE TO DETERMINE. THE DEVICE AND EXTENSION WERE REPLACED ON (B) (6) 2009. THE PT ALSO RECEIVED BOTOX TO THE POSTERIOR CERVICAL MUSCLE WITH PLANS TO REPEAT AS NEEDED. THE HCP REPORTED THE PT OUTCOME AS "NO INJURY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SOLETRA MHY MDT PUERTO RICO OPERATIONS CO., JUNCOS 7426 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Required Intervention IMPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION MODEL: 7482, LOT# NHU063008V| PROGRAMMER: MODEL PROGRAMMER, LOT# UNK| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3387, LOT# J0437427V| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482, LOT# NHU048638V| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT# J0437239V| LOT# NFW142345H| IMPLANTABLE NEURO STIMULATOR: MODEL 7426