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

Model Number	977A290
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Other applicable concomitant components are: product id: 977a290, serial# (b)(4), product type: lead.Product id: 977a290, serial# (b)(4), product type: lead.Refer to manufacturer report #2649622-2018-20380 for details pertaining to the concomitant components.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a manufacturer representative regarding a patient who was going to trial a spinal cord stimulation system.It was reported that the physician attempted to do a trial, but the trial was aborted because he could not get the lead into the proper location that he desired.The patient is doing fine as of (b)(6) 2018 and there were no adverse events reported.A different trial date is scheduled.There were no further complications reported or anticipated.(b)(6) 2018, (rep): additional information was received from a manufacturer representative (rep).It was reported that the healthcare provider discarded the leads.No further complications are anticipated.

• Brand Name: VECTRIS SURESCAN
• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• MDR Report Key: 8152260
• Report Number: 2649622-2018-20383
• Device Sequence Number: 11155428
• Product Code: LGW
• UDI-Device Identifier: 00643169109377
• UDI-Public: 00643169109377
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/11/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/07/2022
• Device Model Number: 977A290
• Device Catalogue Number: 977A290
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 12/11/2018
• 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: Required Intervention
• Patient Age: 73 YR