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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-2202-30
Device Problems High impedance (1291); Failure to Disconnect (2541)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/25/2022
Event Type  Injury  
Event Description
It was reported that the patient who was implanted with an externalized deep brain stimulator lead, underwent an implantable pulse generator, ipg implant procedure.During the ipg implant procedure, the externalized lead extensions were removed without issue, and the leads were planned to be connected to the ipg utilizing the lead extension.High impedances were noted on the lead.The physician attempted to remove and re-insert the lead into the lead extension, however the lead could not be removed from the lead extension.The lead the extension was cut, and the procedure was prolonged.A few days later the patient underwent a lead revision procedure in which the lead and lead extension were replaced.The patient was doing well post-operatively.
 
Manufacturer Narrative
Additional suspect medical device component involved in the event: brand name: ni, upn: m365db3128550, model: db-3128-55, serial: (b)(4), batch: (b)(4).
 
Event Description
It was reported that the patient who was implanted with an externalized deep brain stimulator lead, underwent an implantable pulse generator, ipg implant procedure.During the ipg implant procedure, the externalized lead extensions were removed without issue, and the leads were planned to be connected to the ipg utilizing the lead extension.High impedances were noted on the lead.The physician attempted to remove and re-insert the lead into the lead extension, however the lead could not be removed from the lead extension.The lead the extension was cut, and the procedure was prolonged.A few days later the patient underwent a lead revision procedure in which the lead and lead extension were replaced.The patient was doing well post-operatively.
 
Manufacturer Narrative
Additional suspect medical device component involved in the event: brand name: ni, upn: m365db3128550, model: db-3128-55, serial: (b)(6), batch: (b)(6).Db-2202-30, serial number (b)(6).Visual inspection of the lead revealed that contact number eight was crushed by the lead extension setscrew.This suggests that the lead was not fully inserted in the lead extension when the setscrew was tightened.When contacts are not properly aligned in the lead extension, it will cause high impedance readings.The instruction for use, ifu instructs the physician to fully insert the lead into the lead extension connector to prevent lead damage, therefore, the likely cause of the event was due to user error.The distal portion of the lead was not returned.Cables were exposed at the damaged portion of the lead.Db-3128-55, serial number (b)(6).Visual inspection of the lead extension revealed that the connector had a stuck lead proximal array within it.The stuck portion of the lead was removed from the lead extension.Additionally, the two proximal end portions of the lead extension were not returned.Cables were exposed at the damaged portion of the lead extension.
 
Manufacturer Narrative
Update to box h10: additional suspect medical device component involved in the event: brand name: ni, upn: m365db3128550, model: db-3128-55, serial: (b)(6), batch: (b)(6).Db-2202-30, serial number (b)(6).Visual inspection of the lead revealed that contact number eight was crushed by the lead extension setscrew.This suggests that the lead was not fully inserted in the lead extension when the setscrew was tightened.When contacts are not properly aligned in the lead extension, it causes high impedance readings and cause difficulty removing the lead from the lead extension.The instruction for use, ifu instructs the physician to fully insert the lead into the lead extension connector to prevent lead damage, therefore, the likely cause of the event was due to user error.The distal portion of the lead was not returned.Cables were exposed at the damaged portion of the lead.Db-3128-55, serial number (b)(6).Visual inspection of the lead extension revealed that the connector had a stuck lead proximal array within it.The stuck portion of the lead was removed from the lead extension.Additionally, the two proximal end portions of the lead extension were not returned.Cables were exposed at the damaged portion of the lead extension.
 
Event Description
It was reported that the patient who was implanted with an externalized deep brain stimulator lead, underwent an implantable pulse generator, ipg implant procedure.During the ipg implant procedure, the externalized lead extensions were removed without issue, and the leads were planned to be connected to the ipg utilizing the lead extension.High impedances were noted on the lead.The physician attempted to remove and re-insert the lead into the lead extension, however the lead could not be removed from the lead extension.The lead the extension was cut, and the procedure was prolonged.A few days later the patient underwent a lead revision procedure in which the lead and lead extension were replaced.The patient was doing well post-operatively.
 
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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 Key15946313
MDR Text Key305138162
Report Number3006630150-2022-06881
Device Sequence Number1
Product Code NHL
UDI-Device Identifier08714729905271
UDI-Public08714729905271
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P150031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 02/27/2023
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? Yes
Device Operator Lay User/Patient
Device Model NumberDB-2202-30
Device Catalogue NumberDB-2202-30
Device Lot Number7078466
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/25/2022
Initial Date FDA Received12/08/2022
Supplement Dates Manufacturer Received01/20/2023
02/21/2023
Supplement Dates FDA Received02/13/2023
02/28/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/28/2022
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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