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U.S. Department of Health and Human Services

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

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CVRX, INC. BAROSTIM NEO; IMPLANTABLE PULSE GENERATOR Back to Search Results
Model Number 2102
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erythema (1840); Unspecified Infection (1930); Implant Pain (4561); Swelling/ Edema (4577)
Event Date 11/07/2022
Event Type  Injury  
Manufacturer Narrative
The results of the investigation are inconclusive at this time, and the reported device was not returned for analysis.Based on the information received, the cause of the reported event could not be conclusively determined.The device history record and sterilization record for this device serial number has been reviewed.No issues or discrepancies were noted during this review that would have contributed to the reported event.The device met material, assembly, and quality control requirements.Cvrx id# (b)(6).
 
Event Description
A barostim system was implanted on (b)(6) 2022.On (b)(6) 2022, the patient experienced redness and swelling at the pocket site.On (b)(6) 2022, the patient experienced pain and swelling, and the ipg pocket was open but the ipg was not exposed.A device explant was performed on (b)(6) 2022, and the csl remained in vivo.The ipg was sent to pathology for analysis, and analysis results were unavailable.The patient was released on (b)(6) 2022, and, as of (b)(6) 2022, the patient was doing well with the infection resolved.Per the physician, the root cause of the infection was unable to be determined.
 
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Brand Name
BAROSTIM NEO
Type of Device
IMPLANTABLE PULSE GENERATOR
Manufacturer (Section D)
CVRX, INC.
9201 west broadway avenue
suite 650
minneapolis MN 55445
Manufacturer (Section G)
CVRX, INC.
9201 west broadway avenue
suite 650
minneapolis MN 55445
Manufacturer Contact
sarah hicks
9201 west broadway avenue
suite 650
minneapolis, MN 55445
MDR Report Key15923277
MDR Text Key304872990
Report Number3007972010-2022-00021
Device Sequence Number1
Product Code DSR
UDI-Device Identifier00859144004432
UDI-Public(01)00859144004432(17)231006
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P180050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 12/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date10/06/2023
Device Model Number2102
Device Catalogue Number100054-202
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/11/2022
Initial Date FDA Received12/06/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/06/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age53 YR
Patient SexMale
Patient RaceBlack Or African American
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