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

Model Number 977A260

Device Problems Break (1069); Difficult to Remove (1528)

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

Event Date 12/02/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported the lead was damaged during lead repositioning.The patient had two leads implanted in their lower back from t8 to t10 and the position of the lead in question was adjusted.A manufacturer representative present at the time of the procedure noted the operating physician used a small amount of force to completely remove the stylet from the lead and that once the stylet was completely out, the physician noted ¿that a wire was attached/connected when the stylet was removed from the lead.¿ it was noted that reposition the lead at the time of implant may have led or contributed to the issue.The damaged lead was removed and replaced with a new lead; the issue was considered resolved at the time of report.There were no surgical interventions planned or performed and the patient was alive with no injury at the time of report.No complications were reported or anticipated.

Manufacturer Narrative

Product id: 97792, lot# unknown, product type: accessory.Product id: neu_stylet_acc, lot# unknown, product type: accessory.Device evaluation: analysis of the lead found the #7 conductor was broken 0.2 cm from the lead¿s proximal end and the stylet coil was stretched at the connector area.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: 9530348
• MDR Text Key: 177186619
• Report Number: 2649622-2019-24541
• Device Sequence Number: 1
• Product Code: LGW
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2020

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: 04/05/2023
• Device Model Number: 977A260
• Device Catalogue Number: 977A260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 03/05/2020
• Supplement Dates FDA Received: 03/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2019
• 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 Age: 55 YR