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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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BOSTON SCIENTIFIC NEUROMODULATION VERCISE; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number DB-1110C
Device Problem Device Displays Incorrect Message (2591)
Patient Problem No Code Available (3191)
Event Date 11/04/2019
Event Type  Injury  
Manufacturer Narrative
Additional suspect devices: model: db-9218-15, serial: (b)(4), vercise m8 adapter 15 cm, product family - dbs-adapters.
 
Event Description
A report was received that the patient was receiving multiple magnet reset error messages on the remote control every day.The patient underwent a revision procedure and the physician replaced the ipg and explanted the m8 lead adaptors.The patient was doing fine post operatively.
 
Event Description
A report was received that the patient was receiving multiple magnet reset error messages on the remote control every day.The patient underwent a revision procedure and the physician replaced the ipg and explanted the m8 lead adaptors.The patient was doing fine post operatively.
 
Manufacturer Narrative
Model db-1110-c, vercise ipg, serial (b)(4).The explanted ipg was analyzed and the complaint was confirmed.The reported error message is power-on-reset message indicating the battery power cycle.The device would not be linked even end-of-charge beeps generated.Internal inspection found that the negative terminal nickel strip of the battery was not welded onto the pcb kovar tab.There is no weld mark on the nickel strip.The device would have been powered by the battery as the connection touched the pcb tab that is covered by protective internal support above.Model db-9218-15, vercise m8 adaptors, serial (b)(4), the explanted lead adaptors were analyzed and no anomalies were found.
 
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Brand Name
VERCISE
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
MDR Report Key9520260
MDR Text Key172734179
Report Number3006630150-2019-07653
Device Sequence Number1
Product Code MHY
UDI-Device Identifier08714729820758
UDI-Public08714729820758
Combination Product (y/n)N
PMA/PMN Number
P150031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 03/10/2020
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? Yes
Device Operator Lay User/Patient
Device Expiration Date08/23/2018
Device Model NumberDB-1110C
Device Catalogue NumberDB-1110C
Device Lot Number19617116
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/06/2020
Initial Date Manufacturer Received 12/15/2019
Initial Date FDA Received12/26/2019
Supplement Dates Manufacturer Received03/03/2020
Supplement Dates FDA Received03/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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