MAUDE Adverse Event Report: MPRI VECTRIS SURESCAN; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number	977A275
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Erythema (1840); Fever (1858); Unspecified Infection (1930); Pain (1994); Chills (2191); Discomfort (2330); Sweating (2444)
Date of Event	03/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received by a manufacture representative (rep) regarding a trial patient with an external neurostimulator for an unknown indication for use.(cervical trial) it was reported that the patient was experiencing fever, chills, sweating and stated that the area where the trial lead was placed was red and sore.It was unknown if there were any contributing factors.It was reported that the patient had had a spinal cord stimulator (scs) trial and a few days after the lead pull, the patient was experiencing pain.The patient went to the hospital and stated that they found an abscess in the epidural space.It was reported that no actions were taken at the time of the reported and it was unknown if the issue was resolved.The rep indicated that they had no further information but would be following up with the healthcare provider (hcp) for more information.It was indicated that the trial began on (b)(6) 2019 and the lead pull was (b)(6) 2019.The customer discarded the lead so it would not be returned for analysis.It was indicated that this was a cervical scs trial.The infection occurred after the scs trial ((b)(6) 2019,post-op).No further complications were reported/anticipated.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Additional information was received from a healthcare provider (hcp) reporting that the patient began their trial on (b)(6) and returned on (b)(6) with good coverage and wanted to go forward with the permanent implant.On (b)(6) the patient called the hcp complaining of redness of the skin, pain in the mid to low back of the insertion point and sweats overnight.The hcp told the patient to got to the er (emergency room) and the patient went.Later that day (b)(6), the hcp spoke with the patient and due to their history of (b)(6) and infections in the past they started them on vancomycin.Later that day the patient was admitted for an ¿id workup¿.On (b)(6) 2019 the patient left.It was reported that they had been on antibiotics.The hcp then told them to go back to the hospital and the patient went for a treatment.When they were in the hospital they received antibiotics, and no surgical intervention was ever recommended or performed.The patient was feeling better and was discharged on (b)(6) 19 with a picc line and antibiotic regimen that a home nurse helped them take their daily.It was reported that the patient has now finished their course of antibiotics and was symptoms free for the past few months.Their abscess was resolved and they were not symptomatic.The patient still plans to go forward with the permanent placement.The patient¿s address and phone number were also reported.No further complications were reported/anticipated.

• Brand Name: VECTRIS SURESCAN
• Common Device Name: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 8417419
• Report Number: 2649622-2019-04296
• Device Sequence Number: 16463265
• Product Code: GZB
• UDI-Device Identifier: 00763000006525
• UDI-Public: 00763000006525
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/04/2022
• Device Model Number: 977A275
• Device Catalogue Number: 977A275
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2019
• Supplement Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 07/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 50 YR