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

Model Number 977A260

Device Problem Break (1069)

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

Event Date 12/27/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider (hcp) via a manufacturer¿s representative (rep).The rep reported that the hcp implanted the lead into the patient, but when he went to remove the stylet, it was stuck in the lead.The rep reported that the lead was removed from the patient.The rep reported that when the stylet was removed, a couple of the electrodes came off on the proximal portion of the lead.The rep reported that a new lead was opened up and the hcp had no issues with the lead or stylet removal.No further complications were reported.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow up report will be sent once analysis is complete.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Analysis of the lead (b)(4) found the proximal end of the connector was pulled out or off.Product analysis #(b)(4): analysis information -- 2018-02-08 20:44:21 cst pli# 10 product id# 977a260 below is unedited, system generated text based on the analysis finding code(s) and test results.Analysis identified that the {x} connector(s) was/were pulled out/off at the proximal end of the lead.{<(><<)>(><(><<)><(><<)>)>comments1>} analysis identified the outer insulation of the lead was {broken//torn} under the {} connector.Analysis determined {} conductor wire(s) {was//were} broken due to overstress/damage.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: 7152196
• MDR Text Key: 96006439
• Report Number: 2649622-2017-15639
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/28/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2021
• Device Model Number: 977A260
• Device Catalogue Number: 977A260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2017
• Initial Date FDA Received: 12/28/2017
• Supplement Dates Manufacturer Received: 12/27/2017; 02/08/2018
• Supplement Dates FDA Received: 01/04/2018; 02/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2017
• 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