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

Model Number DB-2202-45

Device Problem Unintended Movement (3026)

Patient Problem No Code Available (3191)

Event Date 04/30/2020

Event Type  Injury  

Event Description

It was reported that during the implant procedure the lead deviated from its desired trajectory and had to be explanted.A ct, cat scan, was taken intraoperatively following the implant of the lead which showed that the lead deviated medially by 5 mm from the desired location.The physician indicated that the deviation occurred about 20 mm above the target area.The lead was explanted, and the procedure was rescheduled to be completed at a later date.Malfunction of the device is not suspected.The patient is doing well post operatively.The device is in route to the bsn.

Manufacturer Narrative

The returned lead was analyzed, passed all tests performed, and exhibited normal device characteristics.The complaint has been confirmed.The distal tip of the lead is slightly curved.However, the distal end straightness specification was checked, and the returned lead was confirmed to be still within the specification, therefore, the probable cause selected is no problem detected.

Event Description

It was reported that during the implant procedure the lead deviated from its desired trajectory and had to be explanted.A ct, cat scan, was taken intraoperatively following the implant of the lead which showed that the lead deviated medially by 5 mm from the desired location.The physician indicated that the deviation occurred about 20 mm above the target area.The lead was explanted, and the procedure was rescheduled to be completed at a later date.Malfunction of the device is not suspected.The patient is doing well post operatively.The device is in route to the bsn.Additional information was received that the lead was returned and analysis was completed.

• 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: 10081262
• MDR Text Key: 191794957
• Report Number: 3006630150-2020-02165
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729905288
• UDI-Public: 08714729905288
• 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
• Report Date: 07/27/2020

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/29/2021
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 5176587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2020
• Initial Date Manufacturer Received: 04/30/2020
• Initial Date FDA Received: 05/21/2020
• Supplement Dates Manufacturer Received: 07/07/2020
• Supplement Dates FDA Received: 07/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention