MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION VERCISE CARTESIA; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS

Model Number DB-2202-45

Device Problem Positioning Problem (3009)

Patient Problems Therapeutic Effects, Unexpected (2099); No Code Available (3191)

Event Date 03/25/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).

Event Description

A report was received that the dbs study patient experienced insufficient improvement.The patient underwent a lead revision procedure where the left lead was relocated for better results.The event resolved and was assessed as causally related to the initial procedure.No further information regarding the device has been obtained.

Manufacturer Narrative

Date of birth: (b)(6).

Event Description

A report was received that the dbs study patient experienced insufficient improvement.The patient underwent a lead revision procedure where the left lead was relocated for better results.The event resolved and was assessed as causally related to the initial procedure.No further information regarding the device has been obtained.

Event Description

A report was received that the dbs study patient experienced insufficient improvement.The patient underwent a lead revision procedure where the left lead was relocated for better results.The event resolved and was assessed as causally related to the initial procedure.No further information regarding the device has been obtained.

• 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 Key: 8551897
• MDR Text Key: 143120369
• Report Number: 3006630150-2019-01890
• Device Sequence Number: 1
• Product Code: NHL
• Combination Product (y/n): N
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 10/28/2019

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/19/2019
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 21268827
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/01/2019
• Initial Date FDA Received: 04/25/2019
• Supplement Dates Manufacturer Received: 08/26/2019; 10/14/2019
• Supplement Dates FDA Received: 08/26/2019; 10/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 62 YR