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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE DBS; DEEP BRAIN STIMULATOR
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BOSTON SCIENTIFIC NEUROMODULATION VERCISE DBS; DEEP BRAIN STIMULATOR Back to Search Results
Model Number NM-3138-55
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Erosion (1750); Staphylococcus Aureus (2058)
Event Date 12/07/2017
Event Type  Injury  
Manufacturer Narrative
Expiration date: n/i.
 
Event Description
A report was received that the patient was experiencing an infection of the dbs lead implant site.The lead extensions were protruding and part of the lead extension headers were visible through the skin.The physician performed a debridement procedure.The patient remains in the hospital on intravenous antibiotics.
 
Manufacturer Narrative
Additional suspect medical device components involved in the event: model: nm-3138-55 serial: (b)(4) description: 55 cm 8 contact extension kit model: db-2202-45 serial: (b)(4) description: vercise dbs 45cm directional lead kit model: db-1140 serial: (b)(4) description: dbs primary cell ipg, sterile pkg additional information was received that swabs of the scalp wound a heavy growth of (b)(6) was isolated.The patient was sent home with oral antibiotics.The physician was unable to determine if the infection was device or procedure related.The patient is recovering well and no further intervention is planned.A review of the manufacturing documentation for the devices revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.A review of the sterilization documentation for the devices was found to be satisfactory.
 
Event Description
A report was received that the patient was experiencing an infection of the dbs lead implant site.The lead extensions were protruding and part of the lead extension headers were visible through the skin.The physician performed a debridement procedure.The patient remains in the hospital on intravenous antibiotics.
 
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Brand Name
VERCISE DBS
Type of Device
DEEP BRAIN STIMULATOR
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer (Section G)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key7154248
MDR Text Key96035672
Report Number3006630150-2017-05522
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
150031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date05/08/2019
Device Model NumberNM-3138-55
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/04/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/12/2017
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) Hospitalization; Required Intervention;
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