MAUDE Adverse Event Report: NUVECTRA CORPORATION ALGOVITA SPINAL CORD STIMULATION; STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF)

Model Number 1124-60T

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923); Material Protrusion/Extrusion (2979)

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

Event Date 12/07/2018

Event Type  malfunction  

Event Description

It was reported to nuvectra that during implant of a trial lead, the stylet protruded through the distal end of the lead where the lead tip became dislodged.A second lead was inserted with the same result.Subsequently, a third lead was implanted with success.

Manufacturer Narrative

An analysis was performed and revealed the tip plug was missing for both leads.The stylets were protruding out of the tip.Both leads were found to have concentric rings extending away from the tip with a rough appearance typical of the molding process.The detection of these features is evidence that the lead did undergo the tipping and reflow process.Root cause was determined and confirmed by the physician to be excessive force applied as a result of an extremely tight epidural space (physician confirmation via mri).A device history review was performed did not reveal any discrepancies that would have contributed to this event.Capa-(b)(4) has been initiated to address the issue.

• Brand Name: ALGOVITA SPINAL CORD STIMULATION
• Type of Device: STIMULATOR, SPINAL CORD, TOTALLY IMPLANTABLE (PAIN RELIEF)
• Manufacturer (Section D): NUVECTRA CORPORATION; 10675 naples street ne; blaine MN 55449
• Manufacturer (Section G): NUVECTRA CORPORATION; 10675 naples street ne; blaine MN 55449
• Manufacturer Contact: david douglas ; 10675 naples street ne; blaine, MN 55449 ; 7634047531
• MDR Report Key: 8215766
• MDR Text Key: 132090227
• Report Number: 3010309840-2019-00143
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P130028
• 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
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2020
• Device Model Number: 1124-60T
• Device Catalogue Number: 1124-60T
• Device Lot Number: W4531261 (2)
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/28/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71 YR