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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-9218-15
Medical Device Problem Codes High impedance (1291); Unexpected Therapeutic Results (1631)
Health Effect - Clinical Code No Code Available (3191)
Date of Event 05/12/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis and the complaint of no stimulation could not be confirmed.Record review revealed no additional information related to the complaint.The investigation is unable to determine a probably cause for the complaint; therefore, the cause cannot be established.
 
Event or Problem Description
It was reported that the patient was not feeling stimulation.It was found that the adaptor had high impedances on each contact.Patient underwent a revision to replace the adaptor and is doing well post-operatively.
 
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Brand Name
VERCISE
Common Device Name
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
MDR Report Key10160086
Report Number3006630150-2020-02485
Device Sequence Number3731970
Product Code MHY
UDI-Device Identifier08714729905196
UDI-Public08714729905196
Combination Product (Y/N)N
Initial Reporter CountryFR
PMA/510(K) Number
P150031
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2020
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 06/16/2020
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
Operator of Device Lay User/Patient
Device Expiration Date10/29/2021
Device Model NumberDB-9218-15
Device Catalogue NumberDB-9218-15
Device Lot Number7070019
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 05/20/2020
Initial Report FDA Received Date06/16/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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