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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CVRX, INC. BAROSTIM NEO; CAROTID SINUS LEAD
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CVRX, INC. BAROSTIM NEO; CAROTID SINUS LEAD Back to Search Results
Model Number 1036
Device Problems Low impedance (2285); Material Deformation (2976); Material Split, Cut or Torn (4008)
Patient Problems High Blood Pressure/ Hypertension (1908); Twiddlers Syndrome (4563)
Event Date 12/23/2021
Event Type  Injury  
Event Description
On (b)(6) 2021, a patient follow-up occurred.The lead impedance was checked, and the lead, implanted on the right carotid, showed low.At previous follow-ups, the lead impedance had been 765 ohms.The patient reported they also weren't feeling good, and their blood pressure was high again.An attempt was made to increase therapy amplitude to get a response from the patient, but the patient did not respond to the increased therapy level.Therapy was turned off to conserve battery life, and a lead replacement was planned.A procedure was performed on (b)(6) 2021, and it was found that the ipg was no longer sutured to the muscle, and the lead was twisted and broken near the ipg.The ipg had been sutured to the muscle at the time of the initial implant, and the physician determined that the patient was a twiddler which had caused the event.The lead was replaced, and the ipg was resutured to the muscle.The lead was activated on (b)(6) 2022, and the patient was doing fine.
 
Manufacturer Narrative
Based on the information received, the cause of the reported event was determined by the physician to be due to the patient twiddling the device.As no device was received for analysis, physical investigation of the device was unable to be performed.However, x-rays and images of the significantly twisted lead supported the physician's root cause determination of the patient twiddling the device.The device history 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)(4).
 
Manufacturer Narrative
Based on the information received, the cause of the reported event was determined by the physician to be due to the patient twiddling the device.As no device was received for analysis, physical investigation of the device was unable to be performed.However, x-rays and images of the significantly twisted lead supported the physician's root cause determination of the patient twiddling the device.The device history 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.(b)(4).
 
Event Description
On (b)(6) 2021, a patient follow-up occurred.The lead impedance was checked, and the lead, implanted on the right carotid, showed low.At previous follow-ups, the lead impedance had been 765 ohms.The patient reported they also weren't feeling good, and their blood pressure was high again.An attempt was made to increase therapy amplitude to get a response from the patient, but the patient did not respond to the increased therapy level.Therapy was turned off to conserve battery life, and a lead replacement was planned.A procedure was performed on (b)(6) 2021, and it was found that the ipg was no longer sutured to the muscle, and the lead was twisted and broken near the ipg.The ipg had been sutured to the muscle at the time of the initial implant, and the physician determined that the patient was a twiddler which had caused the event.The lead was replaced, and the ipg was resutured to the muscle.The lead was activated on (b)(6) 2022, and the patient was doing fine.
 
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Brand Name
BAROSTIM NEO
Type of Device
CAROTID SINUS LEAD
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 Key13265939
MDR Text Key285965246
Report Number3007972010-2022-00001
Device Sequence Number1
Product Code DSR
UDI-Device Identifier0085914404265
UDI-Public(01)0085914404265(17)220212
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
P180050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 01/17/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/17/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date02/12/2022
Device Model Number1036
Device Catalogue Number100063-211
Device Lot Number1036002134
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/24/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/12/2020
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 Age30 YR
Patient SexFemale
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