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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CVRX, INC. NEO LEGACY; IMPLANTABLE PULSE GENERATOR
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CVRX, INC. NEO LEGACY; IMPLANTABLE PULSE GENERATOR Back to Search Results
Model Number 2100
Device Problem Structural Problem (2506)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 03/17/2017
Event Type  Injury  
Manufacturer Narrative
Surgeon discussed issue with patient and patient did not want device explanted, so surgeon agreed to attempt to place the device deeper under the skin and suture.Patient has been on antibiotics due to ongoing systemic infection.Patient will be monitored for signs of infection.On (b)(6) 2017, patient returned and showed signs of infection.Area was opened and showed large amount of pus that was cleaned and a system removal date has been scheduled for (b)(6) 2017.Device remains implanted at this time.
 
Event Description
On (b)(6) 2017, (b)(6), a nurse at (b)(6), contacted cvrx to state that a portion of the right lead for the system was exposed.Cvrx had a call with the surgeon and recommended system removal.Patient did not wish to have the system removed and on (b)(6) 2017, a surgical procedure was performed to place the lead deeper under the skin.
 
Manufacturer Narrative
Surgeon discussed issue with patient and patient did not want device explanted, so surgeon agreed to attempt to place the device deeper under the skin and suture.Patient has been on antibiotics due to ongoing systemic infection.Patient will be monitored for signs of infection.On (b)(6) 2017, patient returned and showed signs of a possible infection.Area was opened and showed large amount of pus that was cleaned, a sample was sent to be cultured, and a system removal date was scheduled for (b)(6) 2017.A call was received from (b)(6) on (b)(6) 2017 that the patient had returned for a pre-operative check to assess the situation and whether the patient was healthy enough for the removal surgery.At this visit, the culture results were reviewed and showed negative for any signs of infection.In addition, the site looked much better with no signs of swelling, redness or drainage.The determination was made to leave the device implanted as the recovery seemed to be going well.The patient has continued to get good therapy from the system throughout this event.Device remains implanted at this time.
 
Event Description
On (b)(6) 2017, (b)(6), a nurse at (b)(6), contacted cvrx to state that a portion of the right lead for the system was exposed.Cvrx had a call with the surgeon and recommended system removal.Patient did not wish to have the system removed and on (b)(6) 2017, a surgical procedure was performed to place the lead deeper under the skin.
 
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Brand Name
NEO LEGACY
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
al crouse
9201 west broadway avenue
suite 650
minneapolis, MN 55445
7634167457
MDR Report Key6497329
MDR Text Key72920054
Report Number3007972010-2017-00002
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
Remedial Action Repair
Type of Report Initial,Followup
Report Date 05/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/17/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Physician
Device Expiration Date08/27/2014
Device Model Number2100
Device Catalogue Number100053-301
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/27/2012
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 Age49 YR
Patient Weight100
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