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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION LEAD KIT 45CM; DEEP BRAIN STIMULATOR
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BOSTON SCIENTIFIC NEUROMODULATION LEAD KIT 45CM; DEEP BRAIN STIMULATOR Back to Search Results
Model Number DB-2201-45DC
Device Problem No Apparent Adverse Event (3189)
Patient Problem Anxiety (2328)
Event Date 05/25/2018
Event Type  Injury  
Manufacturer Narrative
Additional suspect medical device components involved in the event: model: db-2201-45dc serial/lot: (b)(4) description: lead kit 45cm.
 
Event Description
A report was received that during a dbs implant procedure, while the physician was drilling, the patient became very anxious.The patient experienced high blood pressure as well as chest pain that radiated down the left arm.The anesthesiologist provided the patient with medication to help with the chest pain and lower the blood pressure.The anesthesiologist confirmed during the procedure that the electrocardiogram was fine.The physician and anesthesiologist believe the patient had an anxiety attack in the operating room.The post-op computed tomography was normal and the patient was doing fine post-operatively.
 
Event Description
A report was received that during a dbs implant procedure, while the physician was drilling, the patient became very anxious.The patient experienced high blood pressure as well as chest pain that radiated down the left arm.The anesthesiologist provided the patient with medication to help with the chest pain and lower the blood pressure.The anesthesiologist confirmed during the procedure that the electrocardiogram was fine.The physician and anesthesiologist believe the patient had an anxiety attack in the operating room.The post-op computed tomography was normal and the patient was doing fine post-operatively.
 
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Brand Name
LEAD KIT 45CM
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 Key7580938
MDR Text Key110444913
Report Number3006630150-2018-02079
Device Sequence Number1
Product Code NHL
UDI-Device Identifier08714729836544
UDI-Public08714729836544
Combination Product (y/n)N
PMA/PMN Number
150031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 06/15/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date11/09/2019
Device Model NumberDB-2201-45DC
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/25/2018
Initial Date FDA Received06/07/2018
Supplement Dates Manufacturer Received06/13/2018
Supplement Dates FDA Received06/15/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/13/2017
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) Required Intervention;
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