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

Model Number 97702

Device Problem Electromagnetic Compatibility Problem (2927)

Patient Problems Abscess (1690); Bacterial Infection (1735); Dysphagia/ Odynophagia (1815); Paresis (1998); Pneumonia (2011); Seizures (2063)

Event Date 03/14/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.If information is provided in the future, a supplemental report will be issued.

Event Description

Remi, j., loesch-biffar, a.M., mehrkens, j., thon, n., seelos, k., pfister, h.W.Stenotrophomonas maltophilia brain abscesses after implantation of motor cortex stimulator.J neurol sci.2019.400: 32-33.Doi: 10.1016/j.Jns.2019.03.010.Summary: we describe the first case of a patient with brain abscesses caused by stenotrophomonas maltophilia as a complication after motor cortex stimulator implantation.Brain abscesses pose a challenge in diagnosis and treatment, because microbiological diagnosis is not always achieved, antibiotic drugs may not penetrate well into the cns and some bacteria have resistances to typical empirical antibiotic drugs.In this case diagnosis was only made after removal of the stimulator and a long term treatment with antibiotic drugs was necessary.As neurostimulation devices become more common, formerly rare bacteria may become a more common complication.Bacteria with biofilm properties and a problematic resistance spectrum like stenotrophomonas maltophilia should be included in the differential diagnosis, because they will not respond to the typical empirical treatment.Reported event: the (b)(6) year old man was admitted to our hospital with a worsening of his right sided hemiparesis.He had a long past medical history, pertinent was a left thalamic ischemia nine years prior and a subsequent development of a thalamic pain syndrome, which was refractory to medical treatment alone.Six months prior to the admission at our hospital, a motor cortex stimulator had been implanted subdurally over his left motor cortex on the day after surgery he had his first right-sided clonic seizures.The seizures were thought to be procedure related, as they had started even before the full activation of the stimulator.The stimulation, once activated, was not judged as a factor for seizure precipitation.Over the course of the next six months, despite antiepileptic drug treatment, his seizures did not subside at a frequency of 1¿2/month and his preexisting mild post-stroke hemiparesis worsened from 4+/5 to 3¿4/5.With magnetic resonance imaging (mri) not possible due to the stimulator, repeated computed tomographies (cts) were limited in their diagnostic value for the metal artifacts from the stimulator (fig.1a).Systemic inflammatory markers were not elevated, he never had fever and no meningeal signs.His thalamic pain syndrome had markedly improved with a 50¿60% pain reduction.After admission to our hospital, a ct scan showed a white matter hypodensity (fig.1b).Cerebrospinal fluid (csf) analysis showed 7 cells/¿l, elevated csf protein (90 mg/dl) and normal csf glucose.Over the next days he developed a status of clonic seizures of the right side, mainly of the face, the neck and the arm, causing dysphagia and eventually aspiration pneumonia.He was admitted to our neurological icu and had to be intubated.A contrast enhanced ct now demonstrated a round, contrast enhancing structure (fig.1c), raising the suspicion of a cerebral abscess.Calculated antibiotic treatment for the initial pneumonia with piperacillin/tazobactam was adapted to meropenem and vancomycin.With the suspicion of intracerebral abscesses, the stimulator was removed after thorough discussion, because it meant the end of the successful treatment of his pain syndrome.Intraoperatively, a purulent infection was found subdurally with involvement of the adjacent cortical tissue and microbiological sampling was performed.Now, an mri was possible and revealed several disseminated abscesses within the left hemisphere on the day following surgery, especially in the subcentral tissue (fig.1d).On the same day, stenotrophomonas maltophilia was isolated from the samples.Antibiotic treatment was adapted to intravenous moxifloxacin and trimethoprim/sulfamethoxazole, the only two available antibiotics this strain was susceptible to.After eight weeks a first abscess size reduction was documented (fig.1e).Additionally, only then could the seizures be controlled.64 days after initiating moxifloxacin and trimethoprim/sulfmethoxazole, the therapy could be stopped after repeated follow-up mris.The patient was seizure free, could be weaned of the ventilator and was transferred to a rehabilitation hospital, where he further improved and was able to stand, walk with a walker and had no speech impairment.His thalamic pain was less than before in the short term follow up.No specific device information provided.

• Brand Name: SURESCAN
• 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: 8880923
• MDR Text Key: 154028533
• Report Number: 3007566237-2019-01735
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/31/2019
• 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
• Patient Age: 74 YR