BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SPINAL CORD STIMULATOR

    MDR report key: 1978609 · Received February 1, 2011

    Report

    Report Number
    3007566237-2011-00780
    Event Type
    Injury
    Date Received
    February 1, 2011
    Date of Event
    September 1, 2010
    Report Date
    January 3, 2011
    Manufacturer
    MEDTRONIC NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P840001
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE INFO FROM THE ARTICLE OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED EVENTS. IT IS ALSO POSSIBLE SEVERAL EVENTS OCCURRED IN ONE PT. THE PT INFO PROVIDED IN SECTION A IS THE AVERAGE FOR ALL THE PTS. AT THIS TIME NO ADDITIONAL INFO WAS AVAILABLE, ADDITIONAL INFO HAS BEEN REQUESTED.

    Description of Event or Problem · 1

    LITERATURE: MAEDA Y, LUNDBY L, BUNTZEN S, LAURBERG S. SUBOPTIMAL OUTCOME FOLLOWING SACRAL NERVE STIMULATION FOR FAECAL INCONTINENCE. BR J SURG. JAN 2011; 98 (1): 140-147. SUMMARY: THE AUTHORS' AIM OF THE STUDY WAS TO IDENTIFY THE INCIDENCE OF SUBOPTIMAL THERAPEUTIC RESPONSES AND ADVERSE EVENTS ASSOCIATED WITH SACRAL NERVE STIMULATION (SNS) FOR FAECAL INCONTINENCE, AND TO DETERMINE THEIR INFLUENCE ON TREATMENT OUTCOME. PROSPECTIVELY COLLECTED DATA FROM 176 PTS WHO UNDERWENT SNS WERE REVIEWED RETROSPECTIVELY. PT VARIABLES AND REPORTABLE EVENTS WERE ANALYZED BY BINARY REGRESSION TO IDENTIFY THE PREDICTORS OF TREATMENT OUTCOME. THE NUMBER OF PTS EXPERIENCING AN EVENT WAS IDENTIFIED HOWEVER WHEN AN EVENT WAS ONGOING OR PERSISTED AND THE PT REQUIRED A CLINIC VISIT (I.E. REPROGRAMMING), EACH EXTRA CLINIC VISIT WAS COUNTED REPEATEDLY MORE THAN ONCE UNDER THE SAME ENTITY OF THE REPORTABLE EVENT. EVENT: LOSS OF EFFICACY WAS EXPERIENCED BY 87 PTS (212 EVENTS). REPROGRAMMING WAS PERFORMED FOR 149 EVENTS AND RESOLVED 38 EVENTS. INCREASING THE STIMULATION AMPLITUDE WITHOUT CHANGING THE ELECTRODE POLE COMBINATIONS WAS PERFORMED FOR 19 EVENTS, BUT RESOLVED ONLY FOUR. SURGICAL INTERVENTIONS INCLUDED REPOSITIONING OF THE LEAD FOR 17 EVENTS (1 WITH SURGICAL REVISION OF THE STIMULATOR IMPLANT SITE) AND REPLACEMENT OF THE STIMULATOR IN NINE EVENTS, AND WERE SUCCESSFUL FOR 14 EVENTS OVERALL. EXPLANTATION OF THE DEVICE (STIMULATOR AND LEAD) WAS PERFORMED FOR 11 EVENTS. LACK OF EFFICACY WAS EXPERIENCED BY 68 PTS (186 EVENTS). REPROGRAMMING WAS PERFORMED FOR 150 EVENTS AND RESOLVED 41 EVENTS. REPOSITIONING OF THE LEAD WAS PERFORMED FOR 15 EVENTS, BUT ONLY RESOLVED THREE. FIVE EVENTS LED TO EXPLANTATION OF THE DEVICE. PAIN OR DISCOMFORT WAS EXPERIENCED BY 67 PTS (126 EVENTS); 29 PTS (45 EVENTS) EXPERIENCED THIS AROUND THE STIMULATOR TREATED WITH REPROGRAMMING/OBSERVATION (24), 11 STIMULATOR SITE REVISIONS, ONE REPOSITIONING OF THE LEAD AND THREE DEVICE REMOVALS. STIMULATOR TYPE DID NOT AFFECT THE INCIDENCE OF PAIN AND/OR DISCOMFORT AROUND THE STIMULATOR. TWENTY ONE PTS (32 EVENTS) EXPERIENCED PAIN OR DISCOMFORT IN THE VAGINA; 27 EVENTS WERE REPROGRAMMED, 3 HAD REPOSITIONING OF THE LEAD AND 2 DEVICES WERE REMOVED. SEVEN PTS (23 EVENTS) EXPERIENCED PAIN OR DISCOMFORT IN THE LEG; 16 EVENTS WERE REPROGRAMMED/OBSERVED, 3 STIMULATORS WERE SWITCHED OFF AND 4 EVENTS HAD REPOSITIONING OF THE LEAD. FOUR PTS (4 EVENTS) EXPERIENCED PAIN OR DISCOMFORT IN THE ANUS; TWO WERE REPROGRAMMED, ONE HAD A STIMULATOR SITE REVISION AND ONE HAD REPOSITIONING OF THE LEAD. ADDITIONALLY, PAIN OR DISCOMFORT WAS EXPERIENCED IN THE BLADDER (4 PTS; 5 EVENTS), LEAD (6 PTS; 4 EVENTS), POSTURAL (2 PTS, 2 EVENTS), ABDOMEN (1 PT, 1 EVENT), BUTTOCK (1 PT, 1 EVENT), SCROTUM (1 PT, 1 EVENT), STIMULATION SENSATION (1 PT, 1 EVENT), WOUND (1 PT, 1 EVENT), UNK (6 PTS, 6 EVENTS). THESE WERE TREATED IN A NON-SURGICAL WAY. FIVE CLINICALLY SUSPECTED INFECTIONS WERE RECORDED; THREE REQUIRED EXPLANTATION OF THE DEVICE (BOTH STIMULATOR AND LEAD), ALTHOUGH THE CULTURE RESULTS WERE NEGATIVE. ONE REQUIRED REMOVAL OF THE LEAD ONLY AND THE CULTURE RESULT WAS POSITIVE. ONE PT WAS TREATED WITH ORAL ANTIBIOTICS. ONE OF THE PTS WHO HAD THE STIMULATOR REMOVED LATER UNDERWENT A SUCCESSFUL REIMPLANTATION. THERE WERE TWO HAEMATOMAS AT THE STIMULATOR SITE, ONE OF WHICH REQUIRED SURGICAL EVACUATION. THREE PTS HAD REPLACEMENT OF THE STIMULATOR OWING TO BATTERY DEPLETION, WHICH OCCURRED AT 43, 74 AND 83 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN SPINAL CORD STIMULATOR LGW MEDTRONIC NEUROMODULATION IPGNEURO NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention LEAD: MODEL UNK, SERIAL# UNK| EXPLANTED:| IMPLANTED: