MAUDE Adverse Event Report: CVRX, INC. NEO LEGACY; IMPLANTABLE PULSE GENERATOR

Model Number 2100

Device Problem Defective Component (2292)

Patient Problems Erosion (1750); Tissue Damage (2104); Injury (2348); Tissue Breakdown (2681); Patient Problem/Medical Problem (2688)

Event Date 01/31/2017

Event Type  Injury  

Event Description

Patient noticed what seemed like a small portion of their lead trying to erode through their skin.The patient experienced "shock like" pains if the area was touched.The patient was seen on (b)(6) 2017, and had been experiencing their symptoms for several weeks prior.The surgeon, dr.(b)(6) examined the patient and reviewed an x-ray of the area.The x-ray showed what appeared to be a small portion of a lead wire without insulation.The location was proximal to the device and appeared to be the non-working left lead.A lead repair had been attempted several years previously on the left lead, however, no information was known about the repair.The patient was getting a good response from the therapy being delivered on the right lead only and impedance of this lead was good.Dr.(b)(6) wanted to remove the damaged part of the left lead without disturbing the ipg as it still had 18 months of battery life.The revision was performed on (b)(6) 2017 without incident.The damaged section of the left lead was actually inside the previously repaired area and not exposed outside the body.Dr.(b)(6) thought the additional material required for the repair was rubbing against the patient's very thin skin and causing discomfort.The damaged section was removed, and they reported it would be returned to cvrx.The remaining right lead had good impedance during and after the procedure and the neo legacy ipg was working properly.The patient has completely recovered.

• Brand Name: NEO LEGACY
• Type of Device: IMPLANTABLE PULSE GENERATOR
• Manufacturer (Section D): CVRX, INC.; 9201 west broadway avenue; suite 650; minneapolis MN 55445 1925
• Manufacturer (Section G): CVRX, INC.; 9201 west broadway avenue; suite 650; minneapolis MN 55445 1925
• Manufacturer Contact: al crouse ; 9201 west broadway ave; suite 650; minneapolis, MN 55445-1925 ; 7634167457
• MDR Report Key: 6496869
• MDR Text Key: 72920716
• Report Number: 3007972010-2017-00001
• Device Sequence Number: 1
• Product Code: DSR
• UDI-Device Identifier: 00859144004166
• UDI-Public: (01)00859144004166(17)160402
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H130007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2017
• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 04/02/2016
• Device Model Number: 2100
• Device Catalogue Number: 100053-301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2014
• 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): Required Intervention
• Patient Age: 58 YR
• Patient Weight: 57