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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE PC; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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BOSTON SCIENTIFIC NEUROMODULATION VERCISE PC; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Model Number DB-1140
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Fall (1848); Bone Fracture(s) (1870); Unspecified Tissue Injury (4559); Insufficient Information (4580)
Event Date 01/01/2020
Event Type  Injury  
Manufacturer Narrative
Age or date of birth: exact date unknown, birth year 1955 date of event: exact date unknown, event occurred in 2020.Phone number: (b)(6).
 
Event Description
It was reported that the patient, who is enrolled in the vercise dbs registry clinical trail study, was admitted due to severe pleura fracture.No action was taken and the patient was discharged.The event and the patient have been determined to be recovered and resolved with sequelae.It was indicated that event is unlikely related to procedure and stimulation and not related to the device.
 
Manufacturer Narrative
Block a2: exact date unknown, birth year 1955.Block b3: exact date unknown, event occurred in 2020.Block e1: phone number: (b)(6).
 
Event Description
It was reported that the patient, who is enrolled in the vercise dbs registry clinical trail study, was admitted due to severe pleura fracture.No action was taken and the patient was discharged.The event and the patient have been determined to be recovered and resolved with sequelae.It was indicated that event is unlikely related to procedure and stimulation and not related to the device.It was additionally reported that the patient was admitted to the hospital for recurrent falls.During the hospital stay the patient suffered another fall leading to rib fracture.
 
Event Description
It was reported that the patient, who is enrolled in the (b)(6) vercise dbs registry clinical study, was admitted due to severe pleura fracture.No action was taken and the patient was discharged.The event and the patient have been determined to be recovered and resolved with sequelae.It was indicated that event is unlikely related to procedure and stimulation and not related to the device.It was additionally reported that the patient was admitted to the hospital for recurrent falls.During the hospital stay the patient suffered another fall leading to rib fracture.Additional information was received that the event is not related to the procedure.
 
Manufacturer Narrative
Block a2: exact date unknown, birth year 1955.Block b3: exact date unknown, event occurred in 2020.Block e1: phone number: (b)(6).
 
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Brand Name
VERCISE PC
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
25155 rye canyon loop
valencia CA 91355
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key12022403
MDR Text Key258497058
Report Number3006630150-2021-03049
Device Sequence Number1
Product Code MHY
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P150031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Study,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 04/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Lay User/Patient
Device Expiration Date05/24/2019
Device Model NumberDB-1140
Device Catalogue NumberDB-1140
Device Lot Number20681700
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/24/2017
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) Hospitalization; Other;
Patient SexMale
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