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

Model Number	977A260
Medical Device Problem Codes	Failure to Deliver Energy (1211); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Therapeutic Effects, Unexpected (2099)
Date of Event	01/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id: 97715, serial# (b)(4), implanted: (b)(6) 2017, product type: implantable neurostimulator; product id: 977a260, serial# (b)(4), implanted: (b)(6) 2017, explanted: (b)(6) 2018, product type: lead.Other relevant device(s) are: product id: 97715, serial/lot #: (b)(4), ubd: 14-sep-2018, udi#: (b)(4); product id: 977a260, serial/lot #: (b)(4), ubd: 01-sep-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a patient implanted for non-malignant pain.The patient reported that there was an issue where their leads ¿separated¿ and stopped working, therefore, the had a revision done and new leads were implanted.The patient stated that they are not sure exactly what caused the issue.They mentioned that they were getting injections and they told the healthcare provider that they didn¿t feel stimulation anymore.The patient had an x-ray done, and a lead issue was found.The revision/replacement was done on (b)(6) 2018, which resolved the issue.No further complications were reported or 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: 8633655
• Report Number: 2649622-2019-08775
• Device Sequence Number: 11182735
• Product Code: LGW
• UDI-Device Identifier: 00643169109391
• UDI-Public: 00643169109391
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/22/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/19/2021
• Device Model Number: 977A260
• Device Catalogue Number: 977A260
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2019
• Initial Report FDA Received Date: 05/22/2019
• 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: Required Intervention
• Patient Age: 41 YR