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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CVRX, INC. BAROSTIM LEGACY; CAROTID SINUS LEAD
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CVRX, INC. BAROSTIM LEGACY; CAROTID SINUS LEAD Back to Search Results
Model Number 1014L
Device Problems High impedance (1291); Microbial Contamination of Device (2303)
Patient Problem Subclinical Infection (2247)
Event Date 04/29/2021
Event Type  Injury  
Event Description
Dr.(b)(6) and rn (b)(6) saw the patient for a pre-surgical review prior to a planned ipg replacement for normal battery depletion on (b)(6) 2021.This patient had a previous adverse event (mdr 3007972010-2017-002) where the right lead was removed.A ct/x-ray scan was performed prior to the pre-surgical review and appeared to show that the left lead was also damaged.A check of impedance with the programmer confirmed that the lead impedance was high.Because of the ongoing issues this patient has had, dr.(b)(6)requested a surgical consult with a cvrx surgeon proctor.The patient history and ct/x-ray files were sent to dr.(b)(6) for the consultation.After reviewing the details (b)(6) suspected an ongoing infection in addition to a likely lead break and recommended system explantation.A system explant occurred on (b)(6) 2021, at which time the event became reportable.Although there were no signs of active infection, routine cultures were performed along the carotid lead path.These cultures came back positive for staphylococcus capitis.
 
Manufacturer Narrative
Patient was having surgical check prior to planned ipg replacement due to normal battery depletion.Check showed a high lead impedance with unclear source of lead damage.Patient has history of lead issues and infections along with underlying comorbidity of diabetes.Surgeon felt that there was likely an infection and requested a surgical consult with a cvrx proctor physician.After review of the case, the proctor recommended system removal and this was agreed to by the attending surgeon.No clear sign of infection were seen during removal but cultures from the lead patch showed infection.Because the barostim legacy leads are no longer produced, it is not possible to replace this system when and if the infection resolves.Main cause of abandoning therapy was due to the infection.It should be noted that the identified expected life of the lead is 10 years and this was implanted longer than that time with multiple surgeries due to the other lead issues.Patient was reported on (b)(6) 2021 to have recovered from the system removal and was doing well with no signs of ongoing infection and the doctor is considering halting antibiotic use.
 
Manufacturer Narrative
Patient was having surgical check prior to planned ipg replacement due to normal battery depletion.Check showed a high lead impedance with unclear source of lead damage.Patient has history of lead issues and infections along with underlying comorbidity of diabetes.Surgeon felt that there was likely an infection and requested a surgical consult with a cvrx proctor physician.After review of the case, the proctor recommended system removal and this was agreed to by the attending surgeon.No clear sign of infection were seen during removal but cultures from the lead patch showed infection.Because the barostim legacy leads are no longer produced, it is not possible to replace this system when and if the infection resolves.Main cause of abandoning therapy was due to the infection.It should be noted that the identified expected life of the lead is 10 years and this was implanted longer than that time with multiple surgeries due to the other lead issues.Patient was reported on (b)(6) 2021 to have recovered from the system removal and was doing well with no signs of ongoing infection and the doctor is considering halting antibiotic use.
 
Event Description
Dr.(b)(6) and rn (b)(6) saw the patient for a pre-surgical review prior to a planned ipg replacement for normal battery depletion on (b)(6) 2021.This patient had a previous adverse event (mdr 3007972010-2017-002) where the right lead was removed.A ct/x-ray scan was performed prior to the pre-surgical review and appeared to show that the left lead was also damaged.A check of impedance with the programmer confirmed that the lead impedance was high.Because of the ongoing issues this patient has had, dr.(b)(6)requested a surgical consult with a cvrx surgeon proctor.The patient history and ct/x-ray files were sent to dr.(b)(6) for the consultation.After reviewing the details (b)(6) suspected an ongoing infection in addition to a likely lead break and recommended system explantation.A system explant occurred on (b)(6) 2021, at which time the event became reportable.Although there were no signs of active infection, routine cultures were performed along the carotid lead path.These cultures came back positive for staphylococcus capitis.
 
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Brand Name
BAROSTIM LEGACY
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
al crouse
9201 west broadway avenue
suite 650
minneapolis, MN 55445
7634167457
MDR Report Key12796322
MDR Text Key285402553
Report Number3007972010-2021-00001
Device Sequence Number1
Product Code DSR
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
H130007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 05/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date09/16/2010
Device Model Number1014L
Device Catalogue Number100030-104
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/16/2008
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 Weight100 KG
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