MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION NEU_INS_STIMULATOR; 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 Problem Staphylococcus Aureus (2058)

Event Date 02/19/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: please note that this date is based off of the date that the article was accepted for publication as the event dates were not provided in the published literature.Concomitant medical products: product id: neu_ins_stimulator, lot#: unknown, product type: implantable neurostimulator.Other relevant device(s) are: product id: neu_ins_stimulator, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Arnold, f.W., bishop, s., johnson, d., scott, l., heishman, c., oppy, l., ball, t., sharma, m., angeli, c., ferreira, c., chen, y., harkema, s., boakye, m.Root cause analysis of epidural spinal cord stimulator implant infections with resolution after implementation of an improved protocol for surgical placement.J infect prev.2019.20(4): 185-190.Doi: 10.1177/1757177419844323 summary: placing a spinal stimulator for the purpose of restoring paralysed function is a novel procedure; however, paralysis predisposes people to infection.Preventing surgical site infections is critical to benefit this population.The objective of this study was to review the root cause analysis of postoperative wound infections by a hospital epidemiology team following implantation of epidural spinal cord neurostimulators in patients with chronic spinal cord injury.A team was assembled to review the case of every individual who had been enrolled to receive a neurostimulator at the facility.A root cause analysis was performed evaluating five categories: the patient; equipment; facility/environment; procedure; and personnel.The root cause analysis included 11 patients.Two patients became infected.Three others dehisced their wound without becoming infected.All patients were given preoperative antibiotics on time.A mean of 17 personnel were in the operating room during surgery.Vancomycin powder was used in the patients who either dehisced their wound or became infected.The root cause analysis provides guidance for other institutions performing the same novel procedure.This analysis did not reveal a direct association, but did generate several areas for improvement including increasing pre surgical screening, cleaning transient equipment (e.G., computer screens), limiting traffic in the operating room, using new sterile instruments for each stage of the procedure, not reopening the back incision, not applying vancomycin powder, and using an antimicr obial envelope for the stimulator.Reported events: a (b)(6) female patient (patient 11) experienced a postoperative wound infection.Three weeks after surgery, the patient presented with redness and ultimately was diagnosed with a surgical site infection with subsequent removal of the stimulator.Even though the stimulator was apparently working well enabling the previously paralyzed patient to move voluntarily and stand unassisted, it was necessary to remove it to clear the infection.The patient¿s cultures grew mssa.They were initially treated with meropenem and vancomycin until the pathogen was identified, at which time they were de-escalated to ceftriaxone for six weeks.A (b)(6) male patient (patient 10) experienced a postoperative wound infection.The patient prompted the investigation by being diagnosed with a staphylococcus aureus infection that was treated with cefepime and vancomycin until methicillin-sensitive s.Aureus (mssa) was identified, after which time treatment was narrowed to nafcillin and rifampin for six weeks.The patient responded to treatment without device removal.No specific device information provided.See attached literature article.

• Brand Name: NEU_INS_STIMULATOR
• 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: 9125893
• MDR Text Key: 165548451
• Report Number: 3007566237-2019-02029
• 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: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2019
• Is this an Adverse Event Report?: Yes
• 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: 09/17/2019
• 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