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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 Human-Device Interface Problem (2949); Migration (4003)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/12/2019
Event Type  Injury  
Event Description
A report was received that following an implant procedure, a computed tomography scan was performed on the patient which confirmed that the lead had migrated 20mm from the target area.The physician was not sure how it occurred and possible thought when pulling out the stylet and cannula, the lead moved.The physician also thought it might have occurred during tunneling of the lead down and the locking cap did not hold.The patient was brought back into the operating room later in the day and the physician repositioned the lead.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)
GUIDANT PUERTO RICO, B.V.
no. 12, road 698
,
dorado PR 00646 3311
Manufacturer Contact
talar tahmasian
25155 rye canyon loop
,
valencia, CA 91355
6619494863
MDR Report Key8562065
MDR Text Key143460797
Report Number3006630150-2019-01930
Device Sequence Number1
Product Code NHL
UDI-Device Identifier08714729905288
UDI-Public08714729905288
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 company representative,health
Reporter Occupation Physician
Type of Report Initial
Report Date 04/29/2019
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 Date02/27/2020
Device Model NumberDB-2202-45
Device Catalogue NumberDB-2202-45
Device Lot Number5029650
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/12/2019
Initial Date FDA Received04/29/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/27/2018
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;
Patient Age78 YR
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