BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3342053 · Received September 11, 2013

    Report

    Report Number
    3004209178-2013-16024
    Event Type
    Injury
    Date Received
    September 11, 2013
    Report Date
    August 16, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER. PATIENT PRODUCT ID: 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 37754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. PRODUCT ID: 37746, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3778-75, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4)

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD SURGERY THE DAY OF THE REPORT BECAUSE ¿THEY HAD TO DO SOME REVISIONS ON THE STIMULATOR.¿ ABOUT TWO AND A HALF WEEKS LATER, IT WAS REPORTED THAT THE PATIENT HAD A REVISION ON (B)(6) 2013. THE PATIENT HAD A WOUND INFECTION IN LUMBAR. THE PATIENT HAD WOUND DISCHARGE. NO HOSPITALIZATION WAS REQUIRED AND THE PATIENT OUTCOME WAS NOTED AS A NON-SERIOUS INJURY OR ILLNESS. THE REPORTER NOTED THAT IT MAY LEAD TO COMPLETE EXPLANT IF THE WOUND DID NOT HEAL. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION REPORTED THE PATIENT'S LEAD ((B)(4)) WAS EXPLANTED ON THE DAY OF FOLLOW-UP. IT WAS ALSO REPORTED THE PATIENT HAD AN "ONSET/DIAGNOSIS OF INFECTION" IN (B)(6) 2013. IT WAS NOTED THE PATIENT WAS ADMINISTERED PERIOPERATIVE AND ORAL ANTIBIOTICS. IT WAS STATED THE PATIENT DISPLAYED SYMPTOMS OF REDNESS AND SWELLING. IT WAS NOTED THE PRIMARY LOCATION OF THE PATIENT'S INFECTION WAS THE LEAD TRACK REGION. A CULTURE WAS OBTAINED FROM THE PATIENT'S LUMBAR REGION AND IT WAS REPORTED "0" ORGANISMS WERE CULTURED. IT WAS NOTED THE PATIENT DID NOT HAVE MENINGITIS. THE PATIENT WAS REPORTED TO HAVE AN "ONGOING" OUTCOME AT THE TIME OF FOLLOW-UP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455175 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention