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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 Problems High impedance (1291); Unexpected Therapeutic Results (1631)
Patient Problem No Code Available (3191)
Event Date 11/23/2020
Event Type  Injury  
Manufacturer Narrative
Exact date unknown.(b)(4).Additional suspect medical device components involved in the event: product family: unknown, upn: unknown, model: unknown, serial: unknown, batch: unknow.
 
Event Description
It was reported that the patient experienced a loss of therapy.It was assessed that there were high impedances on the leads.Patient underwent an explant procedure to remove the leads.No further information has been obtained despite good faith efforts.
 
Manufacturer Narrative
Exact date unknown, explant occurred in (b)(6) 2020.Update to additional suspect medical device components involved in the event: product family: dbs-linear leads: upn: (b)(4).Model: db-2202-45; serial: unknown; batch: unknown.
 
Event Description
It was reported that the patient experienced a loss of therapy.It was assessed that there were high impedances on the leads.Patient underwent an explant procedure to remove the leads.No further information has been obtained despite good faith efforts.
 
Manufacturer Narrative
Initial reporter first and last name updated.
 
Event Description
It was reported that the patient experienced a loss of therapy.It was assessed that there were high impedances on the leads.Patient underwent an explant procedure to remove the leads.No further information has been obtained despite good faith efforts.
 
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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)
GUIDANT PUERTO RICO, B.V.
dorado
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
valencia, CA 91355
6619494863
MDR Report Key11020407
MDR Text Key225480330
Report Number3006630150-2020-06223
Device Sequence Number1
Product Code NHL
Combination Product (y/n)N
Reporter Country CodeNO
PMA/PMN Number
P150031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 01/13/2021
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? Yes
Device Operator Lay User/Patient
Device Model NumberDB-2202-45
Device Catalogue NumberDB-2202-45
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/23/2020
Initial Date FDA Received12/16/2020
Supplement Dates Manufacturer Received12/29/2020
12/29/2020
Supplement Dates FDA Received01/05/2021
01/15/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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;
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