MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE NEUROSTIMULATOR FOR SCS; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number NEU_INS_STIMULATOR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Wound Dehiscence (1154); Abscess (1690); Bacterial Infection (1735); Erythema (1840); Fever (1858); Unspecified Infection (1930); Nausea (1970); Pain (1994); Staphylococcus Aureus (2058); Sepsis (2067); Swelling (2091); Fluid Discharge (2686); Test Result (2695)

Event Date 06/04/2017

Event Type  Injury  

Manufacturer Narrative

Literature citation: bendel m.A., o¿brien t., hoelzer b.C., deer t.R., pittelkow t.P., costandi s., walega d.R., azer g., hayek s.M., wang z., eldrige j.S., qu w., rosenow j.M., falowski s.M., neuman s.A., moeschler s.M., wassef c., kim c., niazi t., saifullah t., yee b., kim c., oryhan c.L., warren d.T., lerman i., mora r., hanes m., simopoulos t., sharma s., gilligan c., grace w., ade t., mekhail n.A., hunter j.P., choi d., choi d.Y.Spinal cord stimulator related infections: findings from a multicenter retrospective analysis of 2737 implants.Neuromodulation 2017;20(6): 553¿557.Doi: 10.1111/ner.12636.Please note this date is based off of the article¿s acceptance date as the specific event date was not provided in the published literature.It was not possible to ascertain specific device information from the article or to match the reported events with previously reported events.Additionally, it was not possible to discern specific reported symptoms, interventions, and outcomes for each patient based on the article format.Correspondence has been sent to the author of the article inquiring about individual patient information and additional information regarding the reported events.

Event Description

Article summary: in this study, the authors aimed to provide a large-scale retrospective study of infection management techniques specifically for spinal cord stimulation (scs) implantation.The article contains a multicenter retrospective study of scs implants performed over a seven-year period at 11 unique academic and non-academic institutions in the united states.All infections and related complications in this cohort were analyzed.Within the study of 2737 scs implant procedures, the authors identified all procedures complicated by infection (2.45%).Localized incisional pain and wound erythema were the most common presenting signs.Laboratory studies were performed in the majority of patients, but an imaging study was performed in less than half of these patients.The most common causative organism was staphylococcus aureus and the implantable neurostimulator (ins) pocket was the most common site of an scs-related infection.Explantation was ultimately performed in 52 of the 67 patients (77.6%).Non-explantation salvage therapy was attempted in 24 patients and was successful in resolving the infection in 15 patients without removal of scs hardware components.Reported events: it was reported that 67 patients experienced a spinal cord stimulation (scs) related infection.The median time to infection onset was 27 days following implantation, with a range of 2-967 days including 5 patients who experienced an scs related wound infection greater than 365 days after implantation.Clinical signs and symptoms experienced by the patients included 49 patients with pain, 41 patients with wound erythema, 32 patients with wound drainage, 20 patients with wound swelling, 17 patients with fever, 14 patients with wound dehiscence, and 3 patients with nausea.It was noted that localized surgical site pain was the most common symptom and wound erythema and wound drainage were the most common signs.Laboratory examinations were performed in the majority of cases (57/67).White blood cell (wbc) counts were obtained in 57 patients, while inflammatory markers were obtained in approximately half of patients (erythrocyte sedimentation rate [esr]¿ 29/67), c-reactive protein (crp)¿ 30/67).26 of the 57 patients with an scs infection and a wbc study had a documented abnormal wbc value (>11.0 x 10^9/l).The mean abnormal wbc value for infected patients was 15.0 x 10^9/l (sd 4.52).When inflammatory markers were obtained, esr values were documented as abnormal (>29 mm/h) in 13 of the 29 infected patients and 16 of the 30 infected patients had a crp value above the normal range (>4.0 mg/l).In patients presenting with an infection and having both inflammatory markers examined, crp and esr were both elevated 10 of 16 patients, crp only in 4 of the 16 patients, and esr only in 2 of 16 patients.For patients with infectious presentation, the mean elevated esr was 51.2 mm/h (sd 18.1) and mean elevated crp value was 38.2 mg/l (sd 62.6).For infected patients with an elevated wbc value and inflammatory lab results available, the inflammatory lab studies were elevated in all cases (11/11).The majority of patients had no imaging studies performed as part of the diagnostic workup of the surgical site infection (ssi) (29/47); however, of the 18 patients who underwent an imaging study prior to the treatment of their scs infection, 6 had normal studies, 3 had implantable neurostimulator (ins) pocket abscesses, 4 had anchoring site abscesses, and 1 had evidence of osteomyelitis/discitis.Of the 67 patients with a scs related infection who had cultures obtained, 42 had a positive culture and 13 had a negative culture.Of the 42 patients with positive cultures, 36 were from the ins pocket site, 12 were at the lead anchoring site, and 5 involved the lead tips.Blood cultures were positive for bacterial growth in 2 patients.One of the patients with a positive blood culture had clinical signs of possible sepsis (fever) and the other is reported as a potential unrelated bacteremia seeding the stimulator device.The most common organism isolated from cultures was s.Aureus in 35 patients, including two cases of methicillin resistant strains (mrsa).Pseudomonas aeruginosa was identified in 2 patients, ¿streptococcus species¿ in 1 patient, serratia marcescens in 1 patient, and a mixed flora in 2 patients.The organism that was cultured in the remaining patient was unreported.Treatment included antibiotics for all but 3 of the 67 cases of scs related infections.Concurrent oral and iv antibiotics were prescribed in 27 patients, oral antibiotics only in 19, and iv antibiotics only in 18.Surgical incision and drainage was performed in 12 cases, with 50% of those not requiring further surgical intervention in the form of explantation.For the patients who underwent irrigation and debridement, 11 of the 12 received concurrent treatment with iv and/or oral antibiotics.Eventual system explantation was performed in 52 of the 67 infection cases.14 of the 52 patients who underwent scs explantation had an mri performed following explant.Of those 14 patients, an epidural abscess and infection was diagnosed in 3 of these mri examinations; the clinical outcome of the epidural infection patients was unknown.3 patients required additional surgical intervention beyond explantation to resolve the infection due to recurrent pocket infection including 1 case in which a skin flap was performed by a plastic surgeon.Of the 15 patients who did not require explant of their systems, 9 patients had their infections resolved by antibiotics only and 5 patients required incision and drainage, ultimately allowing for the salvage of their scs systems.The authors noted that it was suspected the salvaged infections were superficial in nature.Ultimately, all infections were resolved through antibiotic treatment, incision and drainage, explant alone, or explant with additional surgery.No further complications were reported or anticipated.See attached literature article.Please note the same 67 scs related infection patients have been previously reported through regulatory report #3007566237-2017-03996, as they were also the subject of that report's corresponding literature article.

• Brand Name: IMPLANTABLE NEUROSTIMULATOR FOR SCS
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6960597
• MDR Text Key: 89693641
• Report Number: 3007566237-2017-04454
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention