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); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Analysis of the epidural needle found the spoon of the needle had a sharp edge on the undercut side.Concomitant medical products: product id: neu_epidural needle, lot# unknown, product type: accessory.Product id: neu_epidural needle, lot# 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#: ; product id: neu_epidural needle, serial/lot #: unknown, ubd: , udi#: this report is a correction.Regulatory report 3007566237-2018-00433 captured the initial report.No further regulatory reports will be submitted under report number 3007566237-2018-00433.If additional information is received it will be captured in this regulatory report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a manufacturer representative concerning a trial patient.An out of box failure was reported.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 demonstrated it today for the representative and she observed it as well.The hcp commented "these needles are terrible." no patient symptoms were reported.No further complications were reported/anticipated.
Additional Manufacturer Narrative
Due to imdrf harmonization, some previously submitted device, method, result, and conclusion codes related to this event may have been updated.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 7554186
• Report Number: 2649622-2018-09020
• Device Sequence Number: 1261684
• 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
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/25/2018

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: 01/12/2022
• Device Model Number: 977D260
• Device Catalogue Number: 977D260
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2018
• Supplement Date Received by Manufacturer: 07/25/2018; 08/08/2018; 10/25/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 07/25/2018; 10/02/2018; 10/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 51 YR