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

Model Number 1124-75

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 09/12/2017

Event Type  malfunction  

Event Description

It was reported to nuvectra that during implant of a permanent lead, the stylet protruded through the distal end of the lead.The lead was replaced and the patient is receiving adequate coverage.No patient harm was reported.

• 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: bob shokoohi ; 10675 naples street ne; blaine, MN 55449 ; 7634047512
• MDR Report Key: 6929805
• MDR Text Key: 90159019
• Report Number: 3010309840-2017-00038
• 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: Health Professional
• Type of Report: Initial
• Report Date: 10/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/08/2019
• Device Model Number: 1124-75
• Device Catalogue Number: 1124-75
• Device Lot Number: W3753060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/12/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/08/2017
• 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: 68 YR