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

Model Number 2412

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Injury (2348)

Event Date 09/15/2016

Event Type  Injury  

Manufacturer Narrative

A device history record review was conducted.Process monitoring for sterile package seal strength was acceptable, pyrogen monitoring was acceptable and the standard sterilization cycle was achieved with passing biological indicator results.No anomalies were noted.(b)(4).Device not returned to manufacturer.

Event Description

The patient developed a severe infection at the electrode site less than 1 month post implant.A full system explant was performed on (b)(6) 2016.As of (b)(6) 2016, the patient was 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: anne reali ; 10675 naples avenue ne; blaine, MN 55449 ; 7634047508
• MDR Report Key: 6139978
• MDR Text Key: 61290374
• Report Number: 3010309840-2016-00011
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 2412
• Device Catalogue Number: 2412
• Device Lot Number: W3432565
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Age: 51 YR