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

Model Number 977A260

Device Problems Break (1069); Difficult to Insert (1316)

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

Event Date 08/15/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 977a260, serial# (b)(4), : product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative concerning leads related to implantable neurostimulator (ins) system during buried lead implant.It was reported healthcare provider (hcp) could not advance the lead (b)(4) nor could he pull the lead back through the needle after having advanced it to a certain point.The hcp attempted turning the tip of needle but the lead was stuck.The physician opened another lead (b)(4).The hcp noted needle appeared bent and found difficulty advancing it through the straight tip needle in the kit when attempting to do so on mayo before attempting implant with patient.The hcp then decided to implant a paddle lead instead of percutaneous lead.No patient symptoms were reported.No further complications were reported/anticipated.

Manufacturer Narrative

Concomitant medical products: product id: 3550-43, product type: accessory.Product id: 3550-43, product type: accessory.Product id: neu_stylet_acc, product type: accessory.Product id: neu_stylet_acc, product type: accessory.Product id: 977a260, serial# (b)(4), product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

No new information.Device returned for analysis.

Manufacturer Narrative

Analysis of the lead (va1sd4d043) determined that no anomalies were identified.The returned device passed all testing in the laboratory.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: 7801710
• MDR Text Key: 117833342
• Report Number: 2649622-2018-13665
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00763000006501
• UDI-Public: 00763000006501
• 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
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2022
• Device Model Number: 977A260
• Device Catalogue Number: 977A260
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2018
• 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
• Patient Age: 58 YR