BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3213235 · Received July 9, 2013

    Report

    Report Number
    3004209178-2013-11488
    Event Type
    Injury
    Date Received
    July 9, 2013
    Report Date
    June 12, 2013
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2008: 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 LATER REPORTED THAT THERE WERE NO FURTHER UPDATES. THE PATIENT HAD NOT SCHEDULED AN APPOINTMENT WITH DOCTOR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST OPERATION IMPEDANCES WERE HIGH AND THAT ALL ELECTRODES WERE GREATER THAN 10,000 OHMS. IT WAS NOTED THAT THE BATTERY WAS REPLACED ON (B)(6) 2013 AND A POST OP VISIT 13 DAYS LATER DISCOVERED THE HIGH IMPEDANCES. NO PATIENT INJURY WAS REPORTED. IT WAS FURTHER NOTED THAT REPROGRAMMING WAS ATTEMPTED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT REPROGRAMING DID NOT RESOLVE THE ISSUE. IT WAS NOTED THAT THE PATIENT HAD AN APPOINTMENT TO DISCUSS REVISION SURGERY AND REPLACEMENT OF LEAD. IT WAS FURTHER NOTED THAT THE APPOINTMENT DATE WAS UNKNOWN.

    Description of Event or Problem · 1

    FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD BEEN SCHEDULED FOR REVISION SURGERY FOR (B)(6) 2013. 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 GOING TO HAVE A REVISION ON MONDAY AND A NEW SYSTEM WAS GOING TO BE IMPLANTED. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PHYSICIAN DECIDED AGAINST A NEW SYSTEM BECAUSE THE PATIENT WAS PRE-AUTHORIZED FOR A LEAD REVISION ONLY. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE LEAD WAS REMOVED AND THAT IT HAD MIGRATED. IT WAS NOTED THAT THE LEAD WAS REPLACED AND GOT GOOD COVERAGE OF THE LEFT ARM AND HAND. IT WAS NOTED THAT THE PATIENT HAD NOT BEEN SEEN POST OP YET BUT THAT HE HAD GOOD COVERAGE ON THE TABLE. IT WAS FURTHER NOTED THAT HIS PAIN WAS PRIMARILY ON THE LEFT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    314212 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 00058 YR Required Intervention