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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 Bacterial Infection (1735); Low Blood Pressure/ Hypotension (1914); Rash (2033); Impaired Healing (2378)
Event Date 09/29/2023
Event Type  Injury  
Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: dbs-lead fixation upn: m365db4600c0 model: db-4600c serial: n/a batch: 31666133.
 
Event Description
It was reported that the deep brain stimulation (dbs) patient developed an infection at the right lead site.There was discoloration and abnormal healing at the site.The physician indicated that the burr hole cover is high profile and contributed to the infection.The patient underwent an explant of the lead and burr hole cover (bhc).The patient remained as an inpatient to be monitored and receive antibiotics.While hospitalized, the patient underwent a computer tomography (ct) scan and experienced an allergic reaction the dye.The patient was later discharged.The patient later returned to the medical facility due to low blood pressure.
 
Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: dbs-lead fixation.Upn: m365db4600c0.Model: db-4600c.Serial: n/a.Batch: 31666133.
 
Event Description
It was reported that the deep brain stimulation (dbs) patient developed an infection at the right lead site.There was discoloration and abnormal healing at the site.The physician indicated that the burr hole cover is high profile and contributed to the infection.The patient underwent an explant of the lead and burr hole cover (bhc).The patient remained as an inpatient to be monitored and receive antibiotics.While hospitalized, the patient underwent a computer tomography (ct) scan and experienced an allergic reaction the dye.The patient was later discharged.The patient later returned to the medical facility due to low blood pressure.Additional information was received that the patient was diagnosed with drug reaction with eosinophilia and systemic symptoms (dress).The patient symptoms were related to an immune response to antibiotics.
 
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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 Key17970351
MDR Text Key326121581
Report Number3006630150-2023-06386
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 11/20/2023
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 Number7107988
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/03/2023
Initial Date FDA Received10/19/2023
Supplement Dates Manufacturer Received11/06/2023
Supplement Dates FDA Received11/20/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/23/2023
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; Required Intervention;
Patient Age76 YR
Patient SexFemale
Patient RaceWhite
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