MAUDE Adverse Event Report: CVRX, INC. CVRX IMPLANTABLE PULSE GENERATOR; STIMULATOR, CAROTID SINUS NERVE

Model Number IPG 2101

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2023

Event Type  Injury  

Event Description

I was part of a human clinical trial for an implanted cvrx device on (b)(6) 2017 at (b)(6) hospital.On (b)(6) 2023 i received a letter that the trial was over and they would be in contact.To date no contact and i know i am in need of a battery replacement.I have reached out to cvrx, (b)(6) hospital and the physician who did the implant and no one seems to know what to do.Cvrx has yet to reply over the past 5 months and i have called them 4 times.My regular cardiologist does not do this procedure.

• Brand Name: CVRX IMPLANTABLE PULSE GENERATOR
• Type of Device: STIMULATOR, CAROTID SINUS NERVE
• Manufacturer (Section D): CVRX, INC.
• MDR Report Key: 17424700
• MDR Text Key: 320172076
• Report Number: MW5120339
• Device Sequence Number: 1
• Product Code: DSR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 08/15/2023
• Device Model Number: IPG 2101
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: ASPRIN 81 MG.; ATORVASTATIN 40 MG.; CLOPIDOGREL 75 MG.; CVRX.; METOPROLOL ER 25 MG.; NITRO (AS NEEDED).; RANOLAZINE ER 1000.; SPIRONOLACTONE 25 MG.
• Patient Outcome(s): Life Threatening
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 100 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White