BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESTORE ULTRA

    MDR report key: 2257028 · Received September 16, 2011

    Report

    Report Number
    3004209178-2011-07891
    Event Type
    Injury
    Date Received
    September 16, 2011
    Date of Event
    February 4, 2009
    Report Date
    January 13, 2012
    Manufacturer
    MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    LEAD MODEL 3986A LOT # UNK IMPLANTED: UNK EXPLANTED: UNK ADAPTER MODEL 74001 LOT # N210464 IMPLANTED: UNK EXPLANTED: UNK ACCESSORY ANCHOR MODEL UNK LOT # UNK IMPLANTED: UNK EXPLANTED: UNK ACCESSORY ANCHOR MODEL UNK LOT # UNK IMPLANTED: UNK EXPLANTED: UNK.

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF LEAD MODEL 3986A LOT # UNKNOWN SHOWED NO SIGNIFICANT ANOMALY. OUTER INSULATION WAS MELTED; CAUTERY WAS SUSPECTED (ARTIFACT). CONTINUITY WAS ACCEPTABLE WITH NO SHORTS BETWEEN CIRCUITS. FINAL ANALYSIS OF EXTENSION MODEL # 748951 LOT # NHU062476V SHOWED NO SIGNIFICANT ANOMALY. EXTENSION/BODY/CUT THROUGH, PRODUCT WAS SEGMENTED. CONDUCTOR WAS CUT; BODY INSULATION CUT THRU, EXTENSION SEGMENTED. NO SHORTS BETWEEN CIRCUITS; CONTINUITY WAS ACCEPTABLE. ADAPTER TO CUT EXTENSION. CUT EXTENSION TO LEAD. FINAL ANALYSIS OF EXTENSION MODEL # 3708340 LOT# NKC003534V SHOWED NO SIGNIFICANT ANOMALY. CUT THROUGH; PRODUCT SEGMENTED. CONDUCTOR CUT. BODY INSULATION CUT THROUGH; EXTENSION SEGMENTED. CONTINUITY WAS ACCEPTABLE; NO SHORTS BETWEEN CIRCUITS. CUT EXTENSION TO LEAD. (B)(4). FINAL ANALYSIS OF LEAD MODEL # 3986 A LOT # UNKNOWN SHOWED NO SIGNIFICANT ANOMALY. LEAD/BODY/OUTER INSULATION MELTED (SUSPECTED CAUTERY ARTIFACT). CONTINUITY ACCEPTABLE; NO SHORTS BETWEEN CIRCUITS. (B)(4). FINAL ANALYSIS OF ADAPTOR MODEL # 74001 LOT # UNKNOWN SHOWED NO ANOMALY FOUND. OUTER INSULATION INTACT. CONTINUITY ACCEPTABLE. NO SHORTS BETWEEN CIRCUITS. (B)(4). FINAL ANALYSIS OF ANCHOR MODEL # UNKNOWN, LOT # UNKNOWN SHOWED NO SIGNIFICANT ANOMALY; ANCHOR CUT, COSMETIC. (B)(4). FINAL ANALYSIS OF ANCHOR MODEL # UNKNOWN, LOT # UNKNOWN SHOWED NO ANOMALY FOUND. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HEADACHE AND/OR BURNING SENSATION IN HER NECK OCCURRED. THE PATIENT SUSPECTED IT WAS A LEAD ISSUE. IMPEDANCE MEASUREMENTS WERE DONE AND THE RESULTS WERE WITHIN A NORMAL RANGE. THE HIGHEST LEAD WAS ONLY AT T10 AND, THEREFORE, PROBABLY WAS NOT CAUSING THE PAIN OR BURNING SENSATION IN THE NECK. THE BURNING SENSATION OR PAIN WERE SPECULATED, BY THE HEALTHCARE PROVIDER, TO BE A RESULT OF POOR BODY MECHANICS SECONDARY TO COPING WITH PAINFUL AREAS IN THE LOWER BODY. THE PATIENT'S TARGET PAIN AREA WAS ACROSS THE LOW BACK AND HER ENTIRE LEFT AND RIGHT LEGS, DOWN THROUGH THE TOES. IT WAS REPORTED THAT THE PATIENT MET WITH A HEALTHCARE PROVIDER AND MANUFACTURER'S REPRESENTATIVE AND WAS REPROGRAMMED MULTIPLE TIMES OVER THE YEARS. THE PATIENT WAS SCHEDULED FOR SURGERY TO FIX THE PROBLEM WITH THEIR SYSTEM ON (B)(6) 2011. THE SURGERY OCCURRED AND RESULTED IN RETAINING THE BATTERY BUT REPLACING 2 LEADS, 2 EXTENSIONS AND ONE POCKET ADAPTOR. THERE WAS NO PRODUCT DEFICIENCY SUSPECTED WITH THE PRODUCT JUST INADEQUATE COVERAGE DUE TO SUB-OPTIMAL PLACEMENT OF THE ORIGINALS, ALTHOUGH SHE HAS HAD SOME SPREAD OF DISEASE. THE OUTCOME OF THE SURGERY WAS OUTSTANDING. IN RECOVERY, THE PATIENT WAS ABLE TO GET COVERAGE IN THE LOW BACK FOR THE FIRST TIME AND FULL COVERAGE OF THE LEGS, FEET AND TOES. THE PATIENT COMPLAINED OF STIMULATION PARESTHESIA IRRITATING THE ACTUAL SURGICAL INCISION IN HER LOW BACK SO THERE WAS A REPROGRAMMING TO COVER THE BUTTOCKS DOWN, STAYING OUT OF THE LOW BACK. THE LEG COVERAGE WAS THE BEST THE PATIENT HAS HAD AND THE PATIENT WAS THRILLED TO KNOW THE STIMULATION WOULD COVER THE LOW BACK ONCE THE INCISION HAD HEALED AND THE SENSITIVITY WAS GONE. LATER, ON (B)(6) 2011, THE PATIENT SAW HER HEALTHCARE PROVIDER WHO GAVE HER SEVERAL PROGRAMS WHICH GAVE GOOD RESULTS. THE PATIENT CONTINUED TO HAVE A SHORT-TERM SENSITIVITY IN THE INCISION FOR THE LEAD'S INSERTION SITE. THE PATIENT FOUND THIS SENSITIVITY IRRITATING WHEN STIMULATION WAS IN THE MIDDLE OF HER LOW BACK PAIN TARGET SITE. THE PATIENT WAS GIVEN PROGRAMS FOR HER LEFT AND RIGHT LEGS WHICH AVOIDED THE INCISION LOCATION AND ONE PROGRAM THAT COVERED IT ALL WHICH THE PATIENT COULD VISIT PERIODICALLY. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RESTORE ULTRA STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF LGW MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS 37712 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7425| EXPLANTED:| EXPLANTED:| LEAD: MODEL 3587A, LOT # LB8145| IMPLANTED:| IMPLANTED:| LOT # NAT154286H| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3986A, LOT # N0045489| IMPLANTED:| EXTENSION: MODEL 37083, LOT # NKC003534V| IMPLANTED:| PROGRAMMER: MODEL 7434A, LOT # NGL010866P| EXPLANTED:| EXTENSION: MODEL 7489, LOT # NHU062476V| IMPLANTED:| LOT # NAT153745H| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7425| EXPLANTED:| EXTENSION: MODEL 37083, LOT # NKC003534V| EXPLANTED:| EXTENSION: MODEL 7495-51, LOT # XR0038242N| EXPLANTED:| EXPLANTED: