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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE GENUS; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

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BOSTON SCIENTIFIC NEUROMODULATION VERCISE GENUS; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS Back to Search Results
Model Number DB-1216
Device Problems Unexpected Therapeutic Results (1631); Wireless Communication Problem (3283)
Patient Problem Shaking/Tremors (2515)
Event Date 07/12/2023
Event Type  Injury  
Manufacturer Narrative
Block b3: exact date unknown, event occurred in (b)(6) 2023.
 
Event Description
It was reported that the deep brain stimulation (dbs) patients remote had difficulty communicating with the implantable pulse generator (ipg) after a procedure.Troubleshooting was attempted however it was assessed that the ipg was not functioning.Therefore, the patient underwent an ipg revision procedure during which the ipg was explanted and replaced.The patient was doing well postoperatively.The explanted ipg will not be returned as it was not released by the medical facility.
 
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Brand Name
VERCISE GENUS
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
cashel road
clonmel
EI  
Manufacturer Contact
erik sherburne
25155 rye canyon loop
valencia, CA 91355
7632920920
MDR Report Key17657545
MDR Text Key322360414
Report Number3006630150-2023-05203
Device Sequence Number1
Product Code NHL
UDI-Device Identifier08714729985044
UDI-Public08714729985044
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P150031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 08/30/2023
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 Model NumberDB-1216
Device Catalogue NumberDB-1216
Device Lot Number547372
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/09/2023
Initial Date FDA Received08/30/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/16/2022
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;
Patient Age67 YR
Patient SexFemale
Patient RaceWhite
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