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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE PRIMARY CELL IPG; DEEP BRAIN STIMULATOR
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BOSTON SCIENTIFIC NEUROMODULATION VERCISE PRIMARY CELL IPG; DEEP BRAIN STIMULATOR Back to Search Results
Model Number DB-1140
Device Problem Telemetry Discrepancy (1629)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/06/2018
Event Type  malfunction  
Event Description
A report was received that the patient underwent an ipg replacement procedure due to communication difficulty.The patient noted that after going through an electronic timer, during a race, the stimulation shut off and communication could not be established with the ipg.The patient was doing well post-operatively.
 
Manufacturer Narrative
Analysis of db-1140 (sn (b)(4)) revealed that the device would not be linked to a test remote control even after several attempts.The device was cut open, and the battery measured.44 volts with an infinite internal resistance.The device was powered up using an external power supply and the contents of memory were captured, the battery profile shows an abrupt drop in battery voltage which is not normal for the end of life characteristics of a good battery.It was concluded that the defective battery is the source of the reported loss of communication.
 
Event Description
A report was received that the patient underwent an ipg replacement procedure due to communication difficulty.The patient noted that after going through an electronic timer, during a race, the stimulation shut off and communication could not be established with the ipg.The patient was doing well post-operatively.
 
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Brand Name
VERCISE PRIMARY CELL IPG
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 Key7569078
MDR Text Key110067924
Report Number3006630150-2018-02014
Device Sequence Number1
Product Code LGW
Combination Product (y/n)N
Reporter Country CodeUK
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 07/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date07/14/2018
Device Model NumberDB-1140
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/23/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/24/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/20/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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