BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SOLETRA

    MDR report key: 2770924 · Received October 3, 2012

    Report

    Report Number
    3004209178-2012-08855
    Event Type
    Injury
    Date Received
    October 3, 2012
    Report Date
    September 7, 2012
    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
    SD, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID, 748251 LOT# SERIAL# (B)(4), IMPLANTED: 2003 (B)(6), EXPLANTED: PRODUCT TYPE EXTENSION PRODUCT ID, 748251 LOT# SERIAL# (B)(4), IMPLANTED: 2003 (B)(6), EXPLANTED: PRODUCT TYPE EXTENSION PRODUCT ID, 3387-40 LOT# J0231061V SERIAL#, IMPLANTED: 2003 (B)(6), EXPLANTED: PRODUCT TYPE LEAD PRODUCT ID, 3387-40 LOT# J0228090V SERIAL#, IMPLANTED: 2003 (B)(6), EXPLANTED: PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD AN APPOINTMENT WITH THEIR DOCTOR PLANNED FOR DECEMBER. IT WAS ALSO NOTED THAT IT WAS VERY DIFFICULT FOR THE PATIENT TO TRAVEL. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS EXPERIENCING "SOME BEHAVIOR CHANGES." IT WAS STATED THAT THE PATIENT HAD A SIX WEEK PERIOD WHERE HE COULD NOT DRESS HIMSELF IN ADDITION TO NOT BEING ABLE TO WALK. IT WAS NOTED THAT THE PATIENT WAS "MUCH BETTER NOW," AND WAS ABLE TO DRESS HIMSELF AND WALK. IT WAS INDICATED THAT THE PATIENT HAD "SOME" UNDERLYING PSYCHIATRIC ISSUES. PATIENT STATUS WAS UNKNOWN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE HEALTH CARE PROVIDER (HCP) REPORTED THAT THE CAUSE OF THE EVENT WAS UNKNOWN AND THAT THE PATIENT DID NOT GO TO THE CLINIC. IT WAS STATED THAT THE PATIENT WAS UNABLE TO WALK OR DRESS HIMSELF FOR A 'SHORT PERIOD OF TIME.' THE PATIENT WAS NOT HOSPITALIZED. IT WAS STATED THAT A REPRESENTATIVE INDICATED THAT THE 'PAIN REP' (PAIN REPRESENTATIVE) HAD INTERROGATED THE STIMULATOR BATTERIES A WEEK PRIOR TO WHEN THE HCP HAD CONTACT WITH THE PATIENT. IT WAS NOT CLEAR IF 'PAIN REP' WAS REFERRING TO A MEDTRONIC REPRESENTATIVE OR NOT. IT WAS STATED THAT 'PER PAIN REP THE BATTERIES WERE NOT NEAR END OF LIFE.' IT WAS REPORTED THAT THE PATIENT HAD AN APPOINTMENT SCHEDULED WITH THE HCP IN (B)(6). NO FURTHER INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD DEEP BRAIN STIMULATOR (DBS) IMPLANTED IN (B)(6) 2003. THE PATIENT WAS FINE ON SUNDAY AND UNABLE TO WALK OR SIT UP BY HIMSELF ON MONDAY. IT HAD BEEN THIS WAY FOR ALMOST 2 WEEKS. THE PATIENT HAD REPLACED BATTERY IN (B)(6) 2006. THE DEEP BRAIN STIMULATOR WAS ON, AND THE PATIENT REPLACED THE PATIENT PROGRAMMER WITH 9 VOLT BATTERY. THE PATIENT STATED THERE WAS NOT PROGRAMMER IN THIS AREA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR Other