BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 1812510 · Received August 16, 2010

    Report

    Report Number
    3004209178-2010-06138
    Event Type
    Injury
    Date Received
    August 16, 2010
    Date of Event
    October 19, 2009
    Report Date
    July 19, 2010
    Manufacturer
    MEDTRONIC RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INS AND LEAD HAVE BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS WHICH IS NOT COMPLETE AS OF DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT EXPERIENCED A RASH OVER MOST OF THE BODY AFTER HAVING THE STIMULATOR IMPLANTED. THE RASH OVER MOST OF THE BODY AFTER HAVING THE STIMULATOR IMPLANTED. THE RASH WORSENED OVER TIME. THE PT WAS GIVEN AN ALLERGY TEST WHEN SEEN BY AN ALLERGIST. THE TEST RESULTS WERE INCONCLUSIVE. THE ALLERGIST DID NOT RULE OUT THAT THE PT REACTED TO SOMETHING FROM THE IMPLANTED SYSTEM. THE PT BELIEVED THERE WAS AN ALLERGIC REACTION TO THE SYSTEM AND REQUESTED THE SYSTEM TO BE REMOVED AND ANALYZED BY THE MANUFACTURER TO HELP DETERMINE THAT CAUSED THE RASH. THE PT STATED THAT THE DEVICE SYSTEM WORKED WELL TO ALLEVIATE PAIN, WHILE IMPLANTED. NO FURTHER DETAILS, PT SYMPTOMS OR OUTCOME WERE PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA LGW MEDTRONIC RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention ACCESSORY: MODEL 37752, LOT#NKA125280N| EXPLANTED: | EXPLANTED: | EXTENSION: MODEL 7489, LOT# NHU097565V| EXTENSION: MODEL 7489, LOT# NHU104276V| IMPLANTABLE NEURO STIMULATOR: MODEL 37702, | IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT# J0555658V| LEAD: MODEL 3487A, LOT# J0555658V| LEAD: MODEL 39565-65, LOT #N216700001| LOT# NKL712127H| PROGRAMMER: MODEL 37743, LOT#NKE134559N| EXTENSION: MODEL 7489, LOT# NHU097565V| EXTENSION: MODEL 7489, LOT# NHU104276V| LOT# NKL712127H| IMPLANTABLE NEURO STIMULATOR: MODEL 37702,| LEAD: MODEL 3487A, LOT# J0555658V| IMPLANTED:| LEAD: MODEL 39565-65, LOT #N216700001| IMPLANTED:| EXPLANTED:| IMPLANTED:| ACCESSORY: MODEL 37752, LOT#NKA125280N| EXPLANTED:| PROGRAMMER: MODEL 37743, LOT#NKE134559N| IMPLANTED:| IMPLANTED:| LEAD: MODEL 3487A, LOT# J0555658V| IMPLANTED: