BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESTORE SENSOR

    MDR report key: 7695166 · Received July 17, 2018

    Report

    Report Number
    3004209178-2018-15953
    Event Type
    Malfunction
    Date Received
    July 17, 2018
    Date of Event
    May 1, 2018
    Report Date
    October 5, 2018
    Manufacturer
    MEDTRONIC MED REL MEDTRONIC PUERTO RICO
    Product Code
    LGW
    UDI-DI
    00613994610430
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED FROM A PATIENT REGARDING THEIR NEUROSTIMULATOR (INS) THAT WAS IMPLANTED FOR LUMBAR RADICULOPATHY AND SPINAL PAIN. IT WAS REPORTED THAT PATIENT WAS HAVING DIFFICULTY WITH HIS STIMULATOR AND WOULD LIKE TO HAVE A MANUFACTURER REPRESENTATIVE COME OUT TO HIS APPOINTMENT ON (B)(6) 2018 TO CHECK THE IMPLANT. PATIENT STATED THAT EVERYTHING IS WORKING FINE EXCEPT WHEN HE IS LAYING DOWN AND HAVE THE APPROPRIATE NUMBER FITS BEST AND GIVE IT 3 MINS, AND LATER WHEN HE IS LAYING DOWN POSITION THE STIMULATION INCREASES A LOT HIGHER THAN WHAT IT SHOULD BE AND IT STINGS HIM PRETTY BAD AND ALL THE OTHER POSITIONS ARE FINE. THE EVENT DATE WAS PROVIDED AS (B)(6) 2018; A SPECIFIC DATE WAS NOT PROVIDED. CALLER DID NOT MENTION ANY TRAUMA/FALLS/ACTIVITY. NO FURTHER COMPLICATIONS WERE REPORTED/ANTICIPATED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE PATIENT. THE PATIENT REPORTED THAT THE LAYING DOWN RATE WOULDN¿T CHANGE. THE PATIENT REPORTED THAT HE WOULD REPROGRAM BUT WOULD STILL GO BACK TO ORIGINAL RATE. THE PATIENT REPORTED THAT HE WOULD LAY IN BED, LAY ON THE FLOOR TO CHANGE THE RATE BUT GOING TO BED AND LAYING ON DOCTOR¿S TABLES RATE REMAINED HIGH. THE PATIENT REPORTED THAT THE STINGING WAS SILL THE SAME. THE PATIENT REPORTED THAT A MANUFACTURER¿S REPRESENTATIVE (REP) REPROGRAMMED HIM ON (B)(4) 2018, LAYING BACK AND STANDING IS ALL UPRIGHT POSITION AND THE REP SAID THAT WHEN HE RECLINES AND LAID IN BED WITH A HEAD LIFT WEDGE, WIRES ARE GETTING CLOSER TO THE SPINAL CORD WHICH INCREASES STIMULATION TO UNCOMFORTABLE. THE PATIENT REPORTED THAT HE NEEDED A RECLINING POSITION ON THE PROGRAM SO HE DIDN¿T HAVE TO CARRY HANDHELD AROUND ALL THE TIME. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    535447 RESTORE SENSOR STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37714 00613994610430

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR