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

Model Number	977A290
Medical Device Problem Codes	Break (1069); Difficult to Insert (1316); Difficult to Remove (1528); Impedance Problem (2950)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Epidural needle was received for analysis.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, 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 3007566237-2018-00337 captured the initial report.No further regulatory reports will be submitted under report number 3007566237-2018-00337.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 healthcare professional (hcp) via a manufacturer representative (rep) regarding a patient who was implanted with a neurostimulator for unknown indications.It was reported that during the implant surgery, the electrodes were getting caught in the needle which prevented the lead from being advanced or pulled back through the distal tip of the curved needle.The rep also reported that there was an out of range impedance on contact 0, even though all impedances were within normal limits intra-op after connecting to the battery.There were no factors identified that might have led or contributed to the issues and troubleshooting was not performed.To resolve the issue, it was noted that the hcp used a 3550-14 and the issue resolved.The patient was alive with no injury.Additional information received from the rep reported that the needle used to insert the lead was being sent back to the manufacture for analysis.The patient's indications for use were reported as complex regional pain syndrome and sciatica.The serial number of the ins was provided.No patient complications were reported.
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.
Additional Manufacturer Narrative
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: 7553454
• Report Number: 2649622-2018-08985
• Device Sequence Number: 176914
• Product Code: LGW
• UDI-Device Identifier: 00643169109377
• UDI-Public: 00643169109377
• 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: 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: 12/20/2021
• Device Model Number: 977A290
• Device Catalogue Number: 977A290
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/27/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/01/2018
• 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: 54 YR