BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLETRA

    MDR report key: 2182209 · Received July 7, 2011

    Report

    Report Number
    3004209178-2011-05172
    Event Type
    Malfunction
    Date Received
    July 7, 2011
    Date of Event
    January 1, 2010
    Report Date
    June 13, 2011
    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
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT WAS EXPERIENCING A SHOCKING OR JOLTING SENSATION ALL THE WAY DOWN HER RIGHT LEG ON (B)(6) 2011. THE SHOCKING HAD FIRST OCCURRED ONCE IN (B)(6) 2010. DURING THE EVENT (B)(6), THE PT RECEIVED A SHOCK IN HER LEFT SHOULDER AND LEFT LEG WHILE SITTING IN HER RECLINER. THE PT TURNED OFF THE NEUROSTIMULATOR AT THAT TIME. THE DEVICE WAS INTERROGATED, A CT SCAN WAS ORDERED, AND AN EEG WAS CONDUCTED. THE HEALTHCARE PROVIDER INFORMED THE PT SHE SHOULD TURN HER DEVICE BACK ON AT A LOW LEVEL. THE PT WAS STILL UNABLE TO "LIFT" HER LEFT LEG. THERE WAS NO KNOWN ACCIDENT OR INCIDENT RELATED TO THIS EVENT. ADD'L INFO HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFER TO MFR REPORT # 3004209178-2011-05173.

    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 67 YR IMPLANTED:| LEAD: MODEL 3387, LOT# J0436901V| EXPLANTED:| EXTENSION: MODEL 7482, LOT# NHU064733V| IMPLANTED:| LEAD: MODEL 3387, LOT# J0443929V| EXPLANTED:| EXPLANTED:| EXPLANTED:| IMPLANTED:| EXTENSION: MODEL 7482, LOT# NHU064730V| IMPLANTABLE NEURO STIMULATOR:| EXPLANTED:| IMPLANTED:| MODEL 7426, LOT# NFW122443H| IMPLANTED: