BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE SENSOR

    MDR report key: 3252942 · Received July 29, 2013

    Report

    Report Number
    3004209178-2013-12445
    Event Type
    Injury
    Date Received
    July 29, 2013
    Date of Event
    June 17, 2013
    Report Date
    July 3, 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

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

    Additional Manufacturer Narrative · 1

    CONCOMITANT: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, EXPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION STATED THE PATIENT UNDERWENT REVISION AND REQUESTED TO NOT BE PROGRAMMED POST-OPERATIVELY. IT WAS NOTED THE P ATIENT ¿PREFERRED TO WAIT UNTIL HER ONE WEEK POST-OPERATIVE [APPOINTMENT] DUE TO PAIN.¿ ADDITIONAL INFORMATION REPORTED THE PATIENT DID NOT SHOW UP FOR HER ONE WEEK APPOINTMENT AND WAS RESCHEDULED. ADDITIONAL INFORMATION NOTED THE PATIENT WAS PROGRAMMED AND ¿FELT STIMULATION WHERE SHE NEEDED¿ AND WAS ¿ABLE TO GET 6-8 BARS WITH HER RECHARGER.¿

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT¿S LEADS MIGRATED AND A REVISION WAS SCHEDULED. THE PATIENT HAD A LOSS OF STIMULATION AND A LOSS OF THERAPEUTIC EFFECT. THERE WAS LESS THAN 50% THERAPEUTIC RELIEF. THE DEVICE HAD BEEN REPROGRAMMED. AN XRAY WAS DONE, BUT RESULTS WERE NOT PROVIDED. IT WAS FURTHER REPORTED THAT THE LEAD REVISION WAS SCHEDULED FOR 2013 (B)(6). ADDITIONAL INFORMATION REGARDING OUTCOME WAS REQUESTED, IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352213 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 00043 YR Required Intervention