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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 Staphylococcus Aureus (2058); No Code Available (3191)
Event Date 02/21/2019
Event Type  Injury  
Manufacturer Narrative
Additional suspect medical device component involved in the event: brand name: vercise cartesia, upn: (b)(4), model: db-2202-30, serial: (b)(4).The explanted devices were not returned to bsn as they were discarded by the medical facility.A review of the manufacturing documentation for the devices revealed that no anomalies or deviations potentially related to the event occurred during manufacturing.A review of the sterilization documentation for the devices was found to be satisfactory.
 
Event Description
A report was received that the patient underwent an explant of the lead that was implanted on the right side of the brain.A culture was taken and confirmed that the patient developed staphylococcus aureus.It is unknown which of the two leads was explanted.The patient was also prescribed antibiotics.
 
Event Description
A report was received that the patient underwent an explant of the lead that was implanted on the right side of the brain.A culture was taken and confirmed that the patient developed staphylococcus aureus.It is unknown which of the two leads was explanted.The patient was also prescribed antibiotics.
 
Manufacturer Narrative
Additional information was received that the physician indicated that the infection was procedure related, due to the contamination of the surgical equipment set up for the initial implant of the devices.
 
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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 Key8885752
MDR Text Key154096504
Report Number3006630150-2019-04219
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,foreig
Type of Report Initial,Followup
Report Date 09/10/2019
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 Date06/12/2020
Device Model NumberDB-2202-45
Device Catalogue NumberDB-2202-45
Device Lot Number5064801
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/17/2019
Initial Date FDA Received08/12/2019
Supplement Dates Manufacturer Received08/22/2019
Supplement Dates FDA Received09/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age55 YR
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