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

Model Number 1124-60T

Device Problem Material Separation (1562)

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

Event Date 03/27/2019

Event Type  Injury  

Event Description

It was reported to nuvectra that during the removal of the trial leads, the first lead was removed without issue.The second lead separated and a portion of the lead remained in the patient.The remaining portion of the lead was completely removed and the patient is doing well.

• 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: 8546810
• MDR Text Key: 143057545
• Report Number: 3010309840-2019-00193
• 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
• Report Date: 04/24/2019

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2020
• Device Model Number: 1124-60T
• Device Catalogue Number: 1124-60T
• Device Lot Number: W4644446
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/27/2019
• Initial Date FDA Received: 04/24/2019
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/19/2018
• 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 Outcome(s): Other
• Patient Age: 54 YR