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

Model Number 977A260

Device Problems Difficult to Insert (1316); Insufficient Information (3190)

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

Event Date 12/10/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from the health care provider via the manufacturer representative reporting that there was a lead issue.During the implant procedure the could not slide into the needle.It seemed that something was blocking the progression of the lead into the needle or maybe a default of the lead.The action taken to resolve the event was another lead was opened and everything was good afterwards.The issue was resolved at the time of this report.The patient was alive with no injury.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information received reported that the device was returned.No further complications were reported/anticipated.

Manufacturer Narrative

Product id: neu_stylet_acc, lot# unknown, product type: accessory; product id: 3550-14, lot# unknown, product type: accessory; product id: 3550-14, lot# unknown, product type: accessory.Analysis of the lead (s/n: (b)(4)) found no anomalies.Analysis of the stylet found that the stylet wire was bent.Analysis of the one curve tip needle found no anomalies.Analysis of the other curve tip needle found the introducer to be bent.Fdc 67 pertains to the lead (s/n: (b)(4)), the stylet, and both curve tip needles.Fdm 10 and fdr 213 pertain to the lead (s/n: (b)(4)), the stylet, and both curve tip needles.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VECTRIS SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR 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: 8158453
• MDR Text Key: 130166128
• Report Number: 2649622-2018-20512
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/30/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 08/02/2022
• Device Model Number: 977A260
• Device Catalogue Number: 977A260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 12/12/2018
• Supplement Dates Manufacturer Received: 12/13/2018; 05/04/2019
• Supplement Dates FDA Received: 01/09/2019; 05/30/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2018
• 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