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

Model Number 977A260

Device Problems Break (1069); Difficult to Insert (1316); Blocked Connection (2888)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/22/2017

Event Type  Injury  

Manufacturer Narrative

Analysis of the implantable lead found no anomaly.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.Product id n eu_epiduralneedle, product type accessory.Product id neu_epiduralneedle.Information references the main component of the system.Other relevant device(s) are: product id: neu_epiduralneedle; product id: neu_epiduralneedle.This report is a correction.Regulatory report 3007566237-2018-00087 captured the initial report.No further regulatory reports will be submitted under report number 3007566237-2018-00087.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 Description

Information was received from a manufacturer representative concerning a lead placement issue.It was reported that during implant, the leads were getting caught in the needles and the physician was unable to pull the lead out of the needle when repositioning.The leads were frayed.It was possible that the physician was twisting the needles too much within the needle.They looked at the lead and one was frayed.The lead was not used.No patient injury or symptoms were reported.The leads were going to be returned for analysis.No further complications were reported/anticipated.Additional information was received reporting that there was no associated ins serial number as the case was aborted and rescheduled with paddle leads.No other leads/inss were implanted at the time.The patient¿s weight at the time of the event was unknown.The leads were returned on (b)(6) 2018 and analysis received them on (b)(6) 2018.No further complications were reported/anticipated.The rep provided the patient¿s identifying information.No further complications were reported or anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: VECTRIS SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer (Section G): MPRI; road 149 km 56.3; villalba PR 00766
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7553934
• MDR Text Key: 109562379
• Report Number: 2649622-2018-09005
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109391
• UDI-Public: 00643169109391
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2021
• Device Model Number: 977A260
• Device Catalogue Number: 977A260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR