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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE CARTESIA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
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BOSTON SCIENTIFIC NEUROMODULATION VERCISE CARTESIA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS Back to Search Results
Model Number DB-2202-45
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Hemorrhage, Cerebral (1889); No Code Available (3191)
Event Date 06/12/2020
Event Type  Death  
Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: dbs-linear leads; upn: m365db2202450; model: db-2202-45; serial: (b)(4); batch: (b)(4).
 
Event Description
It was reported that the patient developed an intracerebral hemorrhage, ich, following the implant of the cerebral lead.The patient underwent a procedure in which a ventricular shunt was placed.The event was reported as being related to the procedure because the crw frame may have been misaligned during the procedure thereby resulting in complications during the lead implant.The patient is reported to be in the intensive care unit.No other information was provided.
 
Manufacturer Narrative
Date of death: exact date is unknown, death was over the weekend (b)(6) 2020.
 
Event Description
It was reported that the patient developed an intracerebral hemorrhage, ich, following the implant of the cerebral lead.The patient underwent a procedure in which a ventricular shunt was placed.The event was reported as being related to the procedure because the crw frame may have been misaligned during the procedure thereby resulting in complications during the lead implant.The patient is reported to be in the intensive care unit.Additional information was received that the patient passed away.No other information was provided.
 
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Brand Name
VERCISE CARTESIA
Type of Device
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
MDR Report Key10279580
MDR Text Key199118480
Report Number3006630150-2020-02933
Device Sequence Number1
Product Code NHL
UDI-Device Identifier08714729905288
UDI-Public08714729905288
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,health
Type of Report Initial,Followup
Report Date 08/27/2020
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? No
Device Operator Lay User/Patient
Device Expiration Date02/20/2022
Device Model NumberDB-2202-45
Device Catalogue NumberDB-2202-45
Device Lot Number7072706
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/16/2020
Initial Date FDA Received07/15/2020
Supplement Dates Manufacturer Received08/11/2020
Supplement Dates FDA Received08/27/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death; Hospitalization; Required Intervention;
Patient Age78 YR
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