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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 Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/14/2023
Event Type  malfunction  
Event Description
It was reported that the deep brain stimulation (dbs) lead was bent during an implant procedure.The procedure was successfully completed with an alternate device.The returned lead revealed that the distal array is fractured between electrodes 4 and 5.There was no patient harm due to the reported event.
 
Manufacturer Narrative
The returned lead was analyzed and visual inspection revealed that the distal array is fractured between electrode 4 and 5.A product labeling review identified that the device was used per the instructions for use (ifu) product label and it did not reveal any anomalies, as the ifu states to avoid damaging the lead with sharp instruments or excessive force during surgery.Based on all available information, the reported event of the bent lead was confirmed.The returned lead was analyzed and visual inspection revealed that the distal array is fractured between two lead electrodes.Therefore, with the reported observations and the labeling review, it has been determined that the probable cause was a manufacturing deficiency.
 
Event Description
It was reported that the deep brain stimulation (dbs) lead was bent during an implant procedure.The procedure was successfully completed with an alternate device.The returned lead revealed that the distal array is fractured between electrodes 4 and 5.There was no patient harm due to the reported event.Additional information was received that the lead was bent upon opening the box.
 
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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 Key18647884
MDR Text Key334672025
Report Number3006630150-2024-00498
Device Sequence Number1
Product Code NHL
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 03/01/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberDB-2202-45
Device Catalogue NumberDB-2202-45
Device Lot Number7108489
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/11/2024
Initial Date FDA Received02/05/2024
Supplement Dates Manufacturer Received02/07/2024
Supplement Dates FDA Received03/01/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/06/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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