BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE

    MDR report key: 3130235 · Received May 24, 2013

    Report

    Report Number
    3004209178-2013-08186
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    August 21, 2006
    Report Date
    October 4, 2018
    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
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 377775, LOT# N0036681, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 377775, LOT# N0036681, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 377775, LOT# N0036681, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD; PRODUCT ID 377775, LOT# N0036681, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD. (B)(4).

    Additional Manufacturer Narrative · 1

    INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 377775, LOT# N0036681, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 377775, LOT# N0036681, IMPLANTED: (B)(6) 2006, PRODUCT TYPE LEAD PRODUCT ID: 377775, LOT# N0036681, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. PRODUCT ID: 377775, LOT# N0036681, IMPLANTED: (B)(6) 2006, PRODUCT TYPE: LEAD. EVAL CODE-CONCLUSION: NO LONGER APPLIES.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 377775, LOT# N0036681, IMPLANTED: (B)(6) 2006, EXPLANTED: PRODUCT TYPE LEAD. 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

    PRODUCT ID 377775, LOT# N0036681. IMPLANTED: (B)(6) 2006-08-21. PRODUCT TYPE LEAD, PRODUCT ID 377775, LOT# N0036681, IMPLANTED: (B)(6) 2006-08-21. PRODUCT TYPE LEAD, PRODUCT ID 377775, LOT# N0036681, IMPLANTED: (B)(6) 2006. PRODUCT TYPE LEAD, PRODUCT ID 377775, LOT# N0036681, IMPLANTED: (B)(6) 2006. PRODUCT TYPE LEAD. CONTAINS ALL APPLICABLE CODES AT THIS TIME. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT'S DEVICE "WAS A DUD" AND WAS REPLACED AFTER ONE MONTH. ABOUT ONE WEEK LATER IT WAS REPORTED THAT THE PATIENT HAD "ISSUES WITH THE LEADS" AFTER THE FIRST IMPLANT SURGERY. ONE WEEK AFTER THE PATIENT HAD HER STITCHES REMOVED SHE HAD MENTIONED THE SYSTEM WAS NOT WORKING LIKE THE TRIAL DID. IT WAS STATED THAT THE DOCTOR CHECKED THE LEAD VIA FLUOROSCOPY AND IT DID NOT SHOW THAT HER LEADS MOVED. CHECKING THE SYSTEM REVEALED THAT ONLY 7 OUT OF 18 ELECTRODES WERE WORKING. IT WAS STATED THAT THE DOCTOR "RE-DID" THE SYSTEM ABOUT ONE MONTH LATER AND SINCE THEN "EVERYTHING WORKED WELL".

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE PATIENT ON (B)(6) 2016 REPORTED THAT HER FIRST IMPLANTABLE NEUROSTIMULATOR (INS) WAS DEFECTIVE. THE PATIENT NOTED THAT IT WAS NOT DETERMINED UNTIL HER STITCHES WERE TAKEN OUT. THE PATIENT STATED THAT THE HEALTHCARE PROVIDER (HCP) HAD CHECKED THE INS AND STATED ONLY 8 OR 6 OF THE ELECTRODES WERE WORKING, WHILE THE OTHERS WERE DUDS. THE INS WAS REPLACED TO RESOLVE THE ISSUES AND THE REPLACEMENT WAS EFFECTIVE AND GOT RID OF MOST THE PATIENT'S PAIN.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE CONSUMER ON (B)(6) 2016. THE CONSUMER INQUIRED ABOUT COMPATIBILITY AS THEY PREVIOUSLY NOTED FOR FALLING. THE PATIENT ALSO MENTIONED ONE OF THE PREVIOUS FALLS THAT HAD A CAUSED A 2 IN GASH IN THE SCALP AND HAD THE PATIENT GO TO THE EMERGENCY ROOM (ER) FOR STITCHES. THE PATIENT PREVIOUSLY CONFIRMED THAT THE FALLING WAS UNRELATED TO THE IMPLANT AND THAT NO ALLEGATION TOWARD THE IMPLANT REGARDING THE FALL WAS MENTIONED. IT WAS ALSO NOTED THAT THE PATIENT HAD OR WAS HAVING A CAT SCAN. THE PATIENT MENTIONED PREVIOUSLY DOCUMENTED ISSUES WITH THE PREVIOUS IMPLANT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM A CONSUMER REGARDING THE PATIENT WHO IMPLANTED WITH A NEUROSTIMULATOR FOR SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT WENT THROUGH A TRIAL AND IT WENT EXCELLENT. THEY PUT IN A PERMANENT IMPLANT, SHE WENT IN TO HAVE THE STAPLES REMOVED, AND THE DEVICE WASN¿T WORKING AS WELL AS THE TRIAL. THE HEALTH CARE PROVIDER TRIED REPROGRAMMING IT AND UNDERSTOOD THAT IT IS TRIAL AND ERROR TO PROGRAM THE THERAPY. THE HEALTH CARE PROVIDER CHECKED THE DEVICE TO SEE IF THE LEADS MIGRATED, AND TOLD HER THAT NOT ALL OF THE ELECTRODES WERE WORKING. THE PATIENT STATED A MONTH LATER, THE HEALTH CARE PROVIDER PUT IN A NEW DEVICE BECAUSE HER INITIAL PERMANENT DEVICE WAS ¿DEFECTIVE.¿ THERE WERE NO FURTHER COMPLICATIONS REPORTED OR ANTICIPATED.

    Description of Event or Problem · 1

    PATIENT REPORTED THAT THE FIRST DEVICE WAS REPLACED A MONTH AFTER DUE TO IT BEING DEFECTIVE. PATIENT DID NOT KNOW THEIR WEIGHT AT THE TIME OF THAT EVENT. THE PATIENT STATES THE REASON OF THE REPLACEMENT WAS BECAUSE IT WAS DEFECTIVE. PATIENT STATED THE DEVICE WAS PUT IN AND THEY WENT TO GET STAPLES TAKEN OUT BY THE HCP WHO DID THE IMPLANT. THEY DID NOT KNOW IF THERE WAS EITHER A PROBLEM WITH THE WIRES OR THE DEVICE. FLUOROSCOPE SHOWED THE WIRES HAD NOT MOVED. SURGERY WAS SCHEDULED TO REPLACE THE DEVICE. PATIENT STATES THE REPRESENTATIVE WAS THERE. THE PATIENT WORKED WITH MULTIPLE REPRESENTATIVES DURING THIS EVENT. THE HCP TWEAKED IT A LITTLE BIT. NO FURTHER COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230874 RESTORE STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC MED REL MEDTRONIC PUERTO RICO 37711

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention