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

Model Number	977A275
Medical Device Problem Codes	Difficult to Remove (1528); Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: product id: neu_stylet_acc, lot# unknown, product type: accessory.Product id: 3550-32, lot# unknown, product type: accessory.A supplemental report will be submitted when analysis results are available.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received by a healthcare provider (hcp) via a manufacture representative (rep) regarding a patient with an non-malignant pain.It was reported that the patient¿s lead contacts were catching on the needle tip.There were no known factors that contributed to the issue.The healthcare provider (hcp) exchanged the lead for a different one.The issue was resolved at the time of the report.The lead was never implanted and would be returned for analysis.The event occurred on (b)(6) 2019.Additional information from the manufacturer representative was received on 06/18/2019 reporting that the health care provider (hcp) stated the lead contacts were catching on the exit point of the touhy needle.There was positioning difficulty.The lead was replaced.The patient recovered without sequela and there was no patient injury.No further complications were reported.
Additional Manufacturer Narrative
Product id: neu_stylet_acc, lot# unknown, product type: accessory; product id: 3550-32, lot# unknown, product type: accessory.Analysis of the lead (b)(4)6 found no anomalies.They were able to insert and remove the lead from tuohy needle while rotating the lead with no difficulties.(b)(4).If information is provided in the future, a supplemental report will be issued.

• 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: 8758461
• Report Number: 2649622-2019-11501
• Device Sequence Number: 1342092
• Product Code: LGW
• UDI-Device Identifier: 00763000006525
• UDI-Public: 00763000006525
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/10/2023
• Device Model Number: 977A275
• Device Catalogue Number: 977A275
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 10/04/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 10/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR