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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 Abscess (1690); Bacterial Infection (1735); Convulsion/Seizure (4406)
Event Date 08/31/2023
Event Type  Injury  
Event Description
It was reported that the deep brain stimulation (dbs) patient developed an infection at the right lead incision site after hitting his head on a light socket.The patient was administered antibiotics.Shortly after, the patient experienced a seizure and went to the emergency room.The physician believes that the infection was procedure related and the seizure was procedure and infection related.Magnetic resonance imaging (mri) showed an abscess.The patient underwent an explant the system.The explanted devices were retained by the customer.
 
Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: dbs-linear leads; upn: m365db2202450; model: db-2202-45; serial: (b)(6); batch: 7100625.Product family: dbs-ipg-r-mri; upn: m365db12160; model: db-1216; serial: (b)(6); batch: 571190.
 
Event Description
It was reported that the deep brain stimulation (dbs) patient developed an infection at the right lead incision site after hitting his head on a light socket.The patient was administered antibiotics.Shortly after, the patient experienced a seizure and went to the emergency room.The physician believes that the infection was procedure related and the seizure was procedure and infection related.Magnetic resonance imaging (mri) showed an abscess.The patient underwent an explant the system.The explanted devices were retained by the customer.Additional information was received that culture results indicated heavy growth of methicillin resistant staphylococcus aureus.
 
Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: dbs-linear leads.Upn: m365db2202450.Model: db-2202-45.Serial: (b)(6).Batch:(b)(6).Product family: dbs-ipg-r-mri.Upn: m365db12160.Model: db-1216.Serial: (b)(6).Batch: (b)(6).Product family: dbs-extension.Upn: m365db312855b0.Model: db-3128-55b.Serial: (b)(6).Batch:(b)(6).
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
road 698, lot no. 12
dorado PR 00646 -260
*   00646-2602
Manufacturer Contact
erik sherburne
25155 rye canyon loop
valencia, CA 91355
7632920920
MDR Report Key17775726
MDR Text Key323757155
Report Number3006630150-2023-05681
Device Sequence Number1
Product Code NHL
UDI-Device Identifier08714729905288
UDI-Public08714729905288
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,Followup
Report Date 11/08/2023
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? No
Device Operator Lay User/Patient
Device Model NumberDB-2202-45
Device Catalogue NumberDB-2202-45
Device Lot Number7098142
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 08/31/2023
Initial Date FDA Received09/19/2023
Supplement Dates Manufacturer Received08/31/2023
Supplement Dates FDA Received11/08/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/15/2022
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; Hospitalization;
Patient Age81 YR
Patient SexMale
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