BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3052891 · Received April 11, 2013

    Report

    Report Number
    3004209178-2013-06009
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 26, 2013
    Report Date
    April 25, 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 387445, LOT# VA07EE8, IMPLANTED: (B)(6) 2013. PRODUCT TYPE: SCREENING DEVICE: PRODUCT ID 387445, LOT# VA07EE8. PRODUCT TYPE: SCREENING DEVICE: PRODUCT ID 37746, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013. PRODUCT TYPE: PROGRAMMER, PATIENT: PRODUCT ID 37754, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013. PRODUCT TYPE: RECHARGER: PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013. PRODUCT TYPE: EXTENSION: PRODUCT ID 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013. PRODUCT TYPE: EXTENSION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT TRIAL LEADS WERE USED FOR A PERMANENT IMPLANT. IT WAS NOTED THAT THERE WERE NO PATIENT SYMPTOMS RELATED TO THE EVENT AND THE PATIENT SUFFERED NO INJURY OR ADVERSE EVENT. A WEEK LATER, IT WAS REPORTED THAT THE PATIENT WAS IMPLANTED WITH THE TRIAL LEADS BY ACCIDENT. THREE DAYS LATER IT WAS REPORTED THAT THE PATIENT "WOULD BE TAKEN OUT OF THE WORKFORCE FOR THE REST OF THE YEAR." IT WAS UNCLEAR IF THIS WAS RELATED TO THE DEVICE. IT WAS REPORTED THAT THE PATIENT HAD COMPLICATIONS AND "IT LOOKED LIKE HE GOT HIT BY A TRUCK." IT WAS UNCLEAR WHAT THIS REFERRED TO OR IF IT RELATED TO THE DEVICE. IT WAS INDICATED THAT THE PATIENT PLANNED TO HAVE TO TRIAL LEADS REPLACED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE MANUFACTURER REPRESENTATIVE AND HEALTHCARE PROFESSIONAL WERE NOT AWARE OF CHANGES MADE TO PRODUCT LABELING. IT WAS REPORTED THAT TRIAL LEADS USED TO HAVE BLUE LABELS AND NOW HAVE WHITE LABELS. IT WAS NOTED THAT IMPLANTABLE LEADS ALSO HAVE WHITE LABELS. THE REPORTER STATED THAT THE WRONG LEADS WERE PULLED BECAUSE THE TRIAL LEADS HAD BEEN RESTOCKED TO THE IMPLANTABLE PRODUCT CART. IT WAS REPORTED THAT THE MISTAKE WAS NOT CAUGHT UNTIL THE CASE WAS OVER.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE LEADS AND EXTENSIONS WERE REPLACED ON (B)(6) 2013. IT WAS STATED THAT THE PATIENT WAS SEEN POSTOPERATIVELY AND REPORTED GOOD COVERAGE. THE PATIENT WAS TO HAVE A FOLLOW-UP APPOINT IN THE NEXT WEEK OR TWO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157018 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 00048 YR Required Intervention