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

Model Number	977D260
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Device Damaged Prior to Receipt by User (1570); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of the epidural lead found the spoon of the needle had a sharp edge on the undercut side.Concomitant medical products: product id: neu_epidural needle, serial# unknown, product type: accessory.Information references the main component of the system.Other relevant device(s) are: product id: neu_epidural needle, serial/lot #: unknown, ubd: , udi#: this report is a correction.Regulatory report 3007566237-2018-00434 captured the initial report.No further regulatory reports will be submitted under report number 3007566237-2018-00434.If additional information is received it will be captured in this regulatory report.
Event or Problem Description
Manufacturer representative reported and out of box failure.It was reported that healthcare provider (hcp)complained the curved tip needles provided in leads kits were poor quality.When inserting the lead into the needle, it is not moving smoothly through the hub and once the electrodes exit the needles, it is extremely difficult to retract the lead back into the needle.There was some type of partial occlusion or burr or something like that.He also added that when an electrode is outside of the needle tip, it is difficult to retract and he has to redo the epidural.The hcp commented "these needles are terrible." no patient symptoms were reported.No further complications were reported/anticipated.Additional information was received from a manufacturer representative.It was reported the event occurred during a trial.The affected devices were going to be returned for analysis.No further complications were reported.Additional information was received from a representative (rep) and a healthcare professional (hcp) regarding the patient.It was reported that the electrodes were not passing smoothly through the tip opening of the needle.The rep stated that there was a slight exertion of force to move the electrodes past the needle tip, which produced forceful, rather than smooth movement, when introducing the lead into the epidural space.The physician suspected there were microscopic burrs on the needle tip and that needle tip was not sufficiently polished to eliminate the issue.The rep returned the needles for evaluation.No further complications were reported.Follow up was conducted.

• Brand Name: 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: 7554397
• Report Number: 2649622-2018-09026
• Device Sequence Number: 10814307
• Product Code: LGW
• UDI-Device Identifier: 00643169118249
• UDI-Public: 00643169118249
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 05/30/2018

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: 04/02/2022
• Device Model Number: 977D260
• Device Catalogue Number: 977D260
• Device Lot Number: VA1Q9N4007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2018
• Initial Report FDA Received Date: 05/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1