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

Model Number 2408

Device Problem High impedance (1291)

Patient Problems Nausea (1970); Weakness (2145); Burning Sensation (2146); Dizziness (2194)

Event Date 02/13/2018

Event Type  Injury  

Event Description

It was reported to nuvectra that the patient experienced a burning sensation, tingling in the face, nausea, dizziness, and weakness due to the uncomfortable overstimulation.The device was re-programmed and all impedances are fine.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: 7302784
• MDR Text Key: 101157016
• Report Number: 3010309840-2018-00064
• 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,consum
• Type of Report: Initial
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/22/2018
• Device Model Number: 2408
• Device Catalogue Number: 2408
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/31/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/22/2016
• 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: 77 YR