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

Model Number	977D260
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The epidural needle was evaluated.Analysis of the epidural needle found the spoon of the needle had a sharp edge on the undercut side continuation of medical devices: product id neu_epiduralneedle, product type accessory.Information references the main component of the system.Other relevant device(s) are: product id: neu_epiduralneedle.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The healthcare professional (hcp) reported via the manufacturer representative that while placing the lead in the epidural space they couldn¿t pull the lead back as it got stuck in the needle.The hcp pulled out the needle and lead and was able to pull the lead out of the needle from the distal end of the needle.The hcp then placed the lead in another needle and that worked fine.It was noted that it was the curved needle in the kit that would not allow them to pull the lead back out of the needle properly.The issue was resolved at the time of the report.No patient symptoms reported.
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: 7555351
• Report Number: 2649622-2018-09066
• Device Sequence Number: 19161818
• Product Code: LGW
• UDI-Device Identifier: 00643169118249
• UDI-Public: 00643169118249
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 11/07/2018

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: 02/21/2022
• 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: 05/01/2018
• Supplement Date Received by Manufacturer: 07/26/2018; 08/08/2018; 11/07/2018
• Initial Report FDA Received Date: 05/30/2018
• Supplement Report FDA Received Date: 07/26/2018; 10/02/2018; 11/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1