BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 3041339 · Received April 8, 2013

    Report

    Report Number
    3004209178-2013-04875
    Event Type
    Injury
    Date Received
    April 8, 2013
    Report Date
    March 21, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    MHY
    PMA / PMN Number
    P960009
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 37602 LOT# SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR; PRODUCT ID: 37642 LOT# SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID: 3389-40 LOT# J0542962V, IMPLANTED: 2005 (B)(6), PRODUCT TYPE LEAD; PRODUCT ID 748251 LOT# SERIAL# (B)(4), IMPLANTED: 2005 (B)(6), PRODUCT TYPE EXTENSION; PRODUCT ID: 7482A51 LOT# SERIAL# (B)(4), IMPLANTED: 2007 (B)(6), PRODUCT TYPE EXTENSION; PRODUCT ID: 3387-40 LOT# J0306771V, IMPLANTED: 2003 (B)(6), PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2013. THE PATIENT WAS ADMITTED DUE TO HAVING BEEN "CONFUSED." THE PATIENT HAD BEEN TO THE EMERGENCY ROOM (ER) A WEEK EARLIER WITH THE SIMILAR ISSUES, AND IT WAS FOUND THE PATIENT HAD A URINARY TRACT INFECTION (UTI), A RESPIRATORY INFECTION AND WAS "VERY ILL." FROM THEN, THE PATIENT HAD GOTTEN WORSE ON WEDNESDAY, BETTER, AND THEN WORSE AGAIN ON (B)(6) 2013 WHEN THE PATIENT WAS BROUGHT THE ER AGAIN. THE PATIENT WENT TO A NURSING FACILITY ON (B)(6) 2013 FOR FURTHER CARE. IT WAS REPORTED, THE PATIENT WAS "JERKING" AND THE REPORTER WAS WONDERING IF THE DEVICE HAD COULD HAVE BEEN SHUT OFF, AS THE PATIENT HAD "MANY" CAT SCANS, EKGS, AND "ALL THIS STUFF." IT WAS UNKNOWN HOW LONG THE PATIENT WOULD BE IN THE NURSING FACILITY. THE PATIENT WAS THERE IN AN ATTEMPT TO GET HIS "MEDS ADJUSTED RIGHT." IT WAS NOTED, THE PATIENT WASN'T SLEEPING RIGHT, AND WAS HAVING A "TERRIBLE TIME" INCLUDING HALLUCINATING. IT WAS CLARIFIED THAT THE PATIENT HAD NOT NECESSARILY HAD HALLUCINATIONS THE DAY HE WAS ADMITTED TO THE HOSPITAL, BUT WAS JUST "CONFUSED." THE REPORTER WAS UNABLE TO CHECK IF THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WAS ON AT THE TIME OF REPORT DUE TO NOT HAVING BEEN WITH THE PATIENT. PATIENT OUTCOME WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. REFER TO MANUFACTURER REPORT #3004209178-2013-04871 FOR CONCOMITANT IMPLANTABLE NEUROSTIMULATOR. IT WAS UNCLEAR IF THE PATIENT HAD BOTH DEVICES IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143321 SOLETRA STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR MHY MEDTRONIC MED REL MEDTRONIC PUERTO RICO 7426

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization