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

Model Number 1084-75

Device Problem High impedance (1291)

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

Event Date 05/10/2018

Event Type  malfunction  

Event Description

It was reported to nuvectra a revision of the stimulator was performed due to high impedance readings.During the revision surgery, the physician noticed a fractured lead that was caused by a broken anchor.Subsequently, the stimulator and lead were replaced.

• 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: 7876323
• MDR Text Key: 120708572
• Report Number: 3010309840-2018-00107
• 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: 09/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/27/2019
• Device Model Number: 1084-75
• Device Catalogue Number: 1084-75
• Device Lot Number: W4023436
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2018
• Initial Date FDA Received: 09/14/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/27/2017
• 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): Required Intervention
• Patient Age: 57 YR