BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3191545 · Received June 26, 2013

    Report

    Report Number
    3004209178-2013-10948
    Event Type
    Injury
    Date Received
    June 26, 2013
    Report Date
    June 7, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD: PRODUCT ID 37746, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE WAS REMOVED DUE TO AN INFECTION. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT PERIOPERATIVE ANTIBIOTICS WERE ADMINISTERED TO PATIENT. IT WAS NOTED THAT THE ONSET OF ANTIBIOTICS TREATMENT WAS GIVEN FOR REDNESS OF INCISION ON (B)(6) 2013. IT WAS REPORTED THAT THE DIAGNOSIS OF INFECTION WAS ON (B)(6) 2013. IT WAS NOTED THAT INCISIONAL WOUND OPENING WAS OBSERVED ON (B)(6) 2013. IT WAS REPORTED THAT THE PRIMARY LOCATION OF INFECTION WAS THE DEVICE POCKET/"GENERATOR". IT WAS NOTED THAT A CULTURE WAS OBTAINED FROM THE INCISION SITE. IT WAS REPORTED THAT THE TYPE OF ORGANISM CULTURED WAS "NO GROWTH". IT WAS NOTED THAT ORAL ANTIBIOTICS TREATMENT WAS INSTITUTED FOR THE INFECTION. IT WAS REPORTED THAT THERE WAS A PARTIAL DEVICE SYSTEM EXPLANT ON (B)(6) 2013. IT WAS REPORTED THAT THE RISK FACTOR THAT APPLIED TO THE STATUS OF THE PATIENT BEFORE IMPLANTATION OF THE DEVICE WERE UNKNOWN. IT WAS NOTED THAT THE INFECTION WAS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290316 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 00041 YR Required Intervention