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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 DB-1110C
Device Problem Premature Discharge of Battery (1057)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/22/2016
Event Type  malfunction  
Event Description
A report was received that the patient was experiencing premature battery depletion after a non-device related hospitalization.The patient had to frequently charge the ipg and as a result the physician elected to replace the ipg.The patient was doing well post-operatively.
 
Manufacturer Narrative
Analysis of ipg db-1110c (s/n (b)(4)) revealed that the complaint of fast battery depletion was confirmed.Upon receipt the device would not be charged nor linked to a test remote control even after two charging attempts.The device was cut open, and the battery measured volts.The device exhibited excessive sleep current leakage and the impedance between vh and ground was low.The source of the device damage was the monopolar electrocautery used to reopen the ipg pocket as stated in the complaint.Electrocautery can transfer destructive current into the dbs leads and/or stimulator (physician¿s manual (b)(4)).
 
Event Description
A report was received that the patient was experiencing premature battery depletion after a non-device related hospitalization.The patient had to frequently charge the ipg and as a result the physician elected to replace the ipg.The patient was doing well post-operatively.
 
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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 Key7359297
MDR Text Key103161068
Report Number3006630150-2018-01069
Device Sequence Number1
Product Code NHL
UDI-Device Identifier08714729820758
UDI-Public08714729820758
Combination Product (y/n)N
Reporter Country CodeCO
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 06/21/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date01/17/2016
Device Model NumberDB-1110C
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/21/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/28/2018
Initial Date FDA Received03/21/2018
Supplement Dates Manufacturer Received06/14/2018
Supplement Dates FDA Received06/21/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/31/2014
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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