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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 Difficult to Remove (1528); Material Twisted/Bent (2981)
Patient Problem No Code Available (3191)
Event Date 02/13/2020
Event Type  Injury  
Event Description
It was reported that following an implant procedure a ct scan was taken and displayed that the lead was not implanted straight.The physician noted that the stylet was difficult to remove and therefore, believes this was the reason the lead was not implanted correctly.The patient underwent a lead replacement procedure and is doing well post operatively.
 
Manufacturer Narrative
The device was not returned for analysis and the complaint of the lead not being implanted correctly due to the stylet being difficult to remove could not be confirmed.Record review revealed no additional information related to the complaint.The investigation is unable to determine a probable cause for the complaint; therefore, the cause cannot be established.H6 evaluation method codes (2) = analysis of production records - 3331.H6 evaluation result codes (1) = no device problem found - 213.H6 evaluation conclusion codes (1) + cause not established - 4315.
 
Event Description
It was reported that following an implant procedure a ct scan was taken and displayed that the lead was not implanted straight.The physician noted that the stylet was difficult to remove and therefore, believes this was the reason the lead was not implanted correctly.The patient underwent a lead replacement procedure and is 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 Key9806380
MDR Text Key182583014
Report Number3006630150-2020-01064
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
Report Date 07/09/2020
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 Expiration Date11/20/2021
Device Model NumberDB-2202-45
Device Catalogue NumberDB-2202-45
Device Lot Number7070838
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/13/2020
Initial Date FDA Received03/09/2020
Supplement Dates Manufacturer Received06/17/2020
Supplement Dates FDA Received07/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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