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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 Use of Device Problem (1670); Failure to Disconnect (2541)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/23/2021
Event Type  Injury  
Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: dbs-extension: upn: m365nm3138550, model: nm-3138-55, serial: (b)(4), batch: 7086455.
 
Event Description
It was reported that during a deep brain stimulation (dbs) implant procedure, the extension boot was tightened incorrectly causing the lead extension boot to stick to the lead.The physician used a drill to cut away the set screw block of the extension boot which resulted in severing the end of the lead.The lead remains in situ and the physician has scheduled a lead replacement surgery.
 
Event Description
It was reported that during a deep brain stimulation (dbs) implant procedure, the extension boot was tightened incorrectly causing the lead extension boot to stick to the lead.The physician used a drill to cut away the set screw block of the extension boot which resulted in severing the end of the lead.The lead remains in situ and the physician has scheduled a lead replacement surgery.Additional information was received that the patient underwent a lead explant.The patient was doing well post-operatively.
 
Manufacturer Narrative
Correction to fu #1 mdr in block h6: health effect impact code.Analysis of the returned lead db-2202-45 (serial number (b)(6)) by visual inspection revealed contact eight was crushed by the set screw of the lead extension and it caused the inability to remove the lead from the lead extension connector.This resulted in lead contact deformation inside the lead extension connector and it permanently prevented the lead from proper insertion or removal from the lead extension connector.Analysis of the lead extension nm-3138-55 (serial number (b)(6)) by visual inspection of the connector block assembly revealed remaining a piece of the leads proximal end was stuck inside the lead extension connector.This resulted in lead contact deformation inside the lead extension connector and it permanently prevented the lead from proper insertion or removal from the lead extension connector.
 
Event Description
It was reported that during a deep brain stimulation (dbs) implant procedure, the extension boot was tightened incorrectly causing the lead extension boot to stick to the lead.The physician used a drill to cut away the set screw block of the extension boot which resulted in severing the end of the lead.The lead remains in situ and the physician has scheduled a lead replacement surgery.Additional information was received that the patient underwent a lead explant.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
MDR Report Key12337737
MDR Text Key267105455
Report Number3006630150-2021-04573
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,health
Type of Report Initial,Followup,Followup
Report Date 10/14/2021
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 Health Professional
Device Expiration Date02/25/2023
Device Model NumberDB-2202-45
Device Catalogue NumberDB-2202-45
Device Lot Number7080354
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/25/2021
Initial Date Manufacturer Received 07/23/2021
Initial Date FDA Received08/18/2021
Supplement Dates Manufacturer Received08/17/2021
09/21/2021
Supplement Dates FDA Received09/08/2021
10/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age54 YR
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