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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 Fever (1858); Unspecified Infection (1930); Staphylococcus Aureus (2058); Swelling (2091); Fluid Discharge (2686); No Code Available (3191)
Event Date 01/24/2019
Event Type  Injury  
Manufacturer Narrative
Date of birth: (b)(6); exact date of birth is unknown.
 
Event Description
A report was received that the patient experienced an infection at the implant site, which was severe.The patient underwent a wound revision and the event is recovering/resolving.The physician assessed the event as possibly related to study procedure, probably related to device hardware, and not related to device stimulation.
 
Event Description
A report was received that the patient experienced an infection at the implant site, which was severe.The patient underwent a wound revision and the event is recovering/resolving.The physician assessed the event as possibly related to study procedure, probably related to device hardware, and not related to device stimulation.
 
Manufacturer Narrative
Additional information was received that the explanted devices will not be returned as they were destroyed on site.Additional suspect medical device component involved in the event: model: db-1140 serial/lot: (b)(4) description: vercise primary cell ipg it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.
 
Manufacturer Narrative
Additional information was received that the patient was admitted to the hospital due to an implantation site infection.Upon admission, the physician noted that there was discharge from the scalp area, above both electrode wounds.The patient also had redness of the neck, swelling, and fever above the electrodes in the neck.The patient then underwent an explant procedure to remove the entire dbs system.Cultures were taken and revealed a (b)(6) infection.The patient was started on iv antibiotics for a period of at least 6 weeks.Postoperatively, the patient remained stable and was discharged 11 days later.Additional suspect medical device components involved in the event: model: nm-3138-55 serial/lot: (b)(4) description: 55cm 8 contact extension.Model: nm-3138-55 serial/lot: (b)(4) description: 55cm 8 contact extension.Model: db-2202-45 serial/lot: (b)(4) description: dbs directional lead sterile kit 45cm.Model: db-4600c serial/lot: (b)(4) description: suretek burr hole cover kit.Model: db-4600c serial/lot: (b)(4) description: suretek burr hole cover kit.It is indicated that the devices will not be returned for evaluation; therefore a failure analysis of the complaint devices could not be completed.A review of the device history records and sterilization documentation for the devices will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.
 
Event Description
A report was received that the patient experienced an infection at the implant site, which was severe.The patient underwent a wound revision and the event is recovering/resolving.The physician assessed the event as possibly related to study procedure, probably related to device hardware, and not related to device stimulation.
 
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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 Key8337763
MDR Text Key136110298
Report Number3006630150-2019-00559
Device Sequence Number1
Product Code NHL
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,foreig
Type of Report Initial,Followup,Followup
Report Date 07/19/2019
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 Date06/26/2020
Device Model NumberDB-2202-45
Device Catalogue NumberDB-2202-45
Device Lot Number5070072
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/25/2019
Initial Date FDA Received02/13/2019
Supplement Dates Manufacturer Received04/16/2019
06/26/2019
Supplement Dates FDA Received05/02/2019
07/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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