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); Material Protrusion/Extrusion (2979)

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

Event Date 02/27/2019

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.A new lead was used and the patient is doing well.

Manufacturer Narrative

An analysis was performed and revealed the lead was found to have concentric circles 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.These observations likely indicate that the root cause of the missing distal tip plug is that the reflow process was performed, but it did not sufficiently reflow the lead tip.The inadequate reflow resulted in the tip of the lead to be not completely sealed and an opening in the tip allowed of the stylet to protrude out the end.A device history review was performed did not reveal any discrepancies that would have contributed to this event.Capa-00048 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
• MDR Report Key: 8461715
• MDR Text Key: 140459593
• Report Number: 3010309840-2019-00175
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• PMA/PMN Number: P130028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• 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: 03/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2020
• Device Model Number: 1124-60T
• Device Catalogue Number: 1124-60T
• Device Lot Number: W4571083, W4562966
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/28/2019
• Date Manufacturer Received: 02/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 78 YR