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

Model Number 977A260

Device Problems Break (1069); Difficult to Insert (1316); Malposition of Device (2616)

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

Event Date 05/23/2019

Event Type  malfunction  

Manufacturer Narrative

Analysis results were not available as of the date of this report.A follow-up report will be submitted when analysis is complete.Concomitant medical products: product id: neu_stylet_acc, product type: accessory.If information is provided in the future, a supplemental report will be issued.

Event Description

The healthcare professional (hcp) reported through a manufacturer representative that the stylet was removed during the procedure and that when an attempt was made to reinsert the lead in order to correct the position of the lead, the stylet could not be inserted as there was resistance.The lead was removed from the patient and checked, at which time it was visually found the part where the resistance was, ¿was clearly damaged.¿ the hcp observed the cause of the issue to be a ¿possibility of malfunction¿ of the product during the procedure.It was stated that trying to insert the stylet forcibly may have led or contributed to the issue.The lead was replaced as a result of the event and the issue was resolved.There were no surgical interventions planned or performed and the patient was alive with no injury at the time of report.It was noted the disease the patient was primarily/originally treated for was a tight filum terminale.

Manufacturer Narrative

Continuation of concomitant products: product id: neu_stylet_acc ,lot# unknown, product type: accessory.Device evaluation: analysis of the lead found the stylet coil was perforated by the stylet 14.4 cm from the lead¿s distal end.Analysis of the stylet wire found the wire was bent in several locations along the length of the wire.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: 8704837
• MDR Text Key: 148200992
• Report Number: 2649622-2019-10341
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2022
• Device Model Number: 977A260
• Device Catalogue Number: 977A260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2018
• 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