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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CVRX, INC. BAROSTIM NEO LEGACY; IMPLANTABLE PULSE GENERATOR
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CVRX, INC. BAROSTIM NEO LEGACY; IMPLANTABLE PULSE GENERATOR Back to Search Results
Model Number 2100
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Unspecified Infection (1930); Pocket Erosion (2013)
Event Date 12/25/2017
Event Type  Injury  
Event Description
On approximately (b)(6) 2018, the patient spoke with (b)(6) at (b)(6) heart and complained of pain, thought the device had moved, and wanted to be seen.The patient is typically seen in (b)(6), but lives in (b)(6), so a follow-up was scheduled at (b)(6).On (b)(6) 2018, the patient was seen and was experiencing redness, skin erosion, possible infection, pain, swelling at the pocket.A replacement was scheduled for (b)(6) 2018.On (b)(46) 2018, the skin had been found to be eroded, and the ipg was explanted.The pocket was cultured and packed with iodoform gauze.The patient has a follow-up appointment on (b)(6) 2018.This event became reportable on (b)(6) 2018.
 
Manufacturer Narrative
On 28-mar-2018, it was reported the patient had a follow-up visit on (b)(6) 2018.The pocket was healing with no evident infection, but the leads were clearly protruding.The patient had an appointment on (b)(6) 2018 with the surgeon to discuss removing the leads up to the carotid region.It was noted that the patient's ipg had migrated to their anterior axilla causing pain and increasing tension on the leads.No additional information was provided regarding the migration.The patient was also prescribed an antibiotic, and wound service was ordered for their wound management.It was also reported the patient was placed on oral ciprofloxacin at 500mg on (b)(6) 2018.The patient had the leads completely removed on (b)(6) 2018, and the leads were sent to pathology.The pocket was also cultured again, the swabs were sent to pathology, and they returned with a stain for gram positive cocci and moderate growth of gram positive cocci in clusters.As of (b)(6) 2018, the patient was stable and recovering and will likely remain in the hospital at least through (b)(6) 2018.The patient stated they thought the issues had started around or shortly after (b)(6) 2017 with the pocket area looking bruised and feeling tender.They initially contacted (b)(6) worried that the device was not keeping their blood pressure under control and thought it may need to be checked.When the patient saw dr.(b)(6) in (b)(6) on (b)(6) 2018, most of the area over the device was bluish/purple and an area of the skin had opened.
 
Event Description
On approximately (b)(6) 2018, the patient spoke with (b)(6) at (b)(6) and complained of pain, thought the device had moved, and wanted to be seen.The patient is typically seen in (b)(6), but lives in (b)(6), so a follow-up was scheduled at (b)(6).On (b)(6) 2018, the patient was seen and was experiencing redness, skin erosion, possible infection, pain, swelling at the pocket.A replacement was scheduled for (b)(46 2018.On (b)(6) 2018, the skin had been found to be eroded, and the ipg was explanted.The pocket was cultured and packed with iodoform gauze.The patient has a follow-up appointment on (b)(6) 2018.This event became reportable on (b)(6) 2018.
 
Manufacturer Narrative
On (b)(6) 2018, it was reported the patient had a follow-up visit on (b)(6) 2018.The pocket was healing with no evident infection, but the leads were clearly protruding.The patient had an appointment on (b)(6) 2018 with the surgeon to discuss removing the leads up to the carotid region.It was noted that the patient's ipg had migrated to their anterior axilla causing pain and increasing tension on the leads.No additional information was provided regarding the migration.The patient was also prescribed an antibiotic, and wound service was ordered for their wound management.It was also reported the patient was placed on oral ciprofloxacin at 500mg on (b)(6) 2018.The patient had the leads completely removed on (b)(6) 2018, and the leads were sent to pathology.The pocket was also cultured again, the swabs were sent to pathology, and they returned with a stain for gram positive cocci and moderate growth of gram positive cocci in clusters.As of (b)(6) 2018, the patient was stable and recovering and will likely remain in the hospital at least through (b)(6) 2018.The patient stated they thought the issues had started around or shortly after christmas 2017 with the pocket area looking bruised and feeling tender.They initially contacted (b)(6) worried that the device was not keeping their blood pressure under control and thought it may need to be checked.When the patient saw dr.(b)(6) in (b)(6) on (b)(6) 2018, most of the area over the device was bluish/purple and an area of the skin had opened.On (b)(6) 2018, it was reported the patient surgically was healing well with no signs of infection; the neck incisions were clean, dry, and intact without erythema, swelling or drainage; right chest incision was about 4 x 6 cm and 2-3 cm deep with no bleeding or granulation tissue present.The patient was overall increasing their activity and strength, their hemodynamics and medications were stable, and their blood pressure was 153/92.There was a right hypoglossal nerve injury during the carotid exploration with the lead removal.The patient's tongue deviates to right side with extension, and they have noted weakness pushing against inside of right cheek compared to left cheek.The patient's speech was slurred, but they have been doing speech therapy and feels like they are improving.The patient did not experience loss of taste.On 15-jun-2018, it was reported that the patient canceled their follow-up visit on (b)(6) 2018 without providing a reason and did not reschedule.The patient had also completed speech therapy.As the patient completed speech therapy and canceled their follow-up visit without rescheduling, it is assumed the patient has recovered.This complaint will be re-opened if additional information is provided.
 
Event Description
On approximately (b)(6) 2018, the patient spoke with (b)(6) and complained of pain, thought the device had moved, and wanted to be seen.The patient is typically seen in (b)(6), but lives in (b)(6), so a follow-up was scheduled at (b)(6).On (b)(6) 2018, the patient was seen and was experiencing redness, skin erosion, possible infection, pain, swelling at the pocket.A replacement was scheduled for (b)(6) 2018.On (b)(6) 2018, the skin had been found to be eroded, and the ipg was explanted.The pocket was cultured and packed with iodoform gauze.The patient has a follow-up appointment on (b)(6) 2018.This event became reportable on 26-feb-2018.
 
Event Description
Approximately on (b)(6) 2018, the patient spoke with (b)(6) heart and complained of pain, thought the device had moved, and wanted to be seen.The patient is typically seen in nebraska, but lives in (b)(6), mn, so a follow-up was scheduled at (b)(6) minnesota.On (b)(6) 2018, the patient was seen and was experiencing redness, skin erosion, possible infection, pain, swelling at the pocket.A replacement was scheduled for on (b)(6) 2018.On (b)(6) 2018, the skin had been found to be eroded, and the ipg was explanted.The pocket was cultured and packed with iodoform gauze.The patient has a follow-up appointment on (b)(6) 2018.This event became reportable on (b)(6) 2018.
 
Manufacturer Narrative
On 28-mar-2018, it was reported the patient had a follow-up visit on (b)(6) 2018.The pocket was healing with no evident infection, but the leads were clearly protruding.The patient had an appointment on (b)(6) 2018 with the surgeon to discuss removing the leads up to the carotid region.It was noted that the patient's ipg had migrated to their anterior axilla causing pain and increasing tension on the leads.No additional information was provided regarding the migration.The patient was also prescribed an antibiotic, and wound service was ordered for their wound management.It was also reported the patient was placed on oral ciprofloxacin at 500mg on (b)(6) 2018.The patient had the leads completely removed on (b)(6) 2018, and the leads were sent to pathology.The pocket was also cultured again, the swabs were sent to pathology, and they returned with a stain for gram positive cocci and moderate growth of gram positive cocci in clusters.As of on (b)(6) 2018, the patient was stable and recovering and will likely remain in the hospital at least through on (b)(6) 2018.The patient stated they thought the issues had started around or shortly after christmas 2017 with the pocket area looking bruised and feeling tender.They initially contacted (b)(6) heart worried that the device was not keeping their blood pressure under control and thought it may need to be checked.When the patient saw dr.(b)(6) in minneapolis on (b)(6) 2018, most of the area over the device was bluish/purple and an area of the skin had opened.On 15-may-2018, it was reported the patient surgically was healing well with no signs of infection; the neck incisions were clean, dry, and intact without erythema, swelling or drainage; right chest incision was about 4 x 6 cm and 2-3 cm deep with no bleeding or granulation tissue present.The patient was overall increasing their activity and strength, their hemodynamics and medications were stable, and their blood pressure was 153/92.There was a right hypoglossal nerve injury during the carotid exploration with the lead removal.The patient's tongue deviates to right side with extension, and they have noted weakness pushing against inside of right cheek compared to left cheek.The patient's speech was slurred, but they have been doing speech therapy and feels like they are improving.The patient did not experience loss of taste.
 
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Brand Name
BAROSTIM NEO LEGACY
Type of Device
IMPLANTABLE PULSE GENERATOR
Manufacturer (Section D)
CVRX, INC.
9201 west broadway avenue
suite 650
minneapolis MN 55445 1925
MDR Report Key7327569
MDR Text Key102015213
Report Number3007972010-2018-00001
Device Sequence Number1
Product Code DSR
UDI-Device Identifier00859144004210
UDI-Public(01)00859144004210(17)180920
Combination Product (y/n)N
PMA/PMN Number
H130007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Other
Type of Report Initial,Followup,Followup,Followup
Report Date 06/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Expiration Date09/20/2018
Device Model Number2100
Device Catalogue Number100053-301
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/27/2018
Was the Report Sent to FDA? No
Date Manufacturer Received01/22/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age72 YR
Patient Weight76
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