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

Model Number	977A260
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: product id: 3550-43, lot/serial#: (b)(4), product type: accessory.Product id: 3550-43, serial/lot #: (b)(4), ubd: 28-apr-2022, udi#: (b)(4).Analysis of the curved tip needle (lot # (b)(4)) found the spoon of the needle had a sharp edge on the undercut side.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a manufacturer¿s representative regarding a patient who was implanted with an implantable neurostimulator (ins).It was reported that advancing the lead through the tip of the needle was difficult- they felt resistance/catching, like the electrode was catching on the tip.The healthcare provider (hcp) used a little finesse to advance the lead through the needle and they were able to complete the case.The impedances were normal.The physician noted that there was a gritty feeling when withdrawing the stylet, which was not the usual feeling.Additional information received from the representative.It was reported that the physician was able to successfully withdraw the stylet and the cause of the difficulty inserting/withdrawing the lead was not determined.This information was confirmed with the physician/account.Additional information received.The patient's information was updated.No further complications 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.

• 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: 7730780
• Report Number: 2649622-2018-12328
• Device Sequence Number: 19092647
• Product Code: LGW
• UDI-Device Identifier: 00643169109391
• UDI-Public: 00643169109391
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 02/28/2019

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: 05/23/2022
• Device Model Number: 977A260
• Device Catalogue Number: 977A260
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 06/27/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 02/26/2019
• Initial Report FDA Received Date: 07/30/2018
• Supplement Report FDA Received Date: 10/02/2018; 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR