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

Model Number 1124-60T

Device Problems Entrapment of Device (1212); Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/27/2017

Event Type  malfunction  

Event Description

It was reported to nuvectra that during the removal of the trial leads, one of the leads separated and a portion of the lead remained in the subcutaneous tissue.The remaining portion of the lead is planned to be removed during permanent implant.

• 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: 6981316
• MDR Text Key: 91002849
• Report Number: 3010309840-2017-00043
• 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: 10/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2019
• Device Model Number: 1124-60T
• Device Catalogue Number: 1124-60T
• Device Lot Number: W3909640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/27/2017
• Initial Date FDA Received: 10/26/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/21/2017
• 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: 46 YR