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

Model Number DB-2202-45

Device Problems Fracture (1260); High impedance (1291)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/19/2021

Event Type  malfunction  

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: (b)(4), model: db-2202-45, serial: (b)(4), batch: 7075773.

Event Description

It was reported that the during a programming appointment high impedances were observed on the patient's leads.The physician, suspecting lead fracture, ordered x-rays to confirm lead fracture.

Event Description

It was reported that the during a programming appointment high impedances were observed on the patient's leads.The physician, suspecting lead fracture, ordered x-rays to confirm lead fracture.Additional information was received that the x-ray did not show a visible fracture.The patient was seen in the clinic and it was determined that no further action will be taken at this time.The lead contacts suggesting the fracture are not being used for the stimulation.

• 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: 11307967
• MDR Text Key: 231305308
• Report Number: 3006630150-2021-00378
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/18/2022
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7075727
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/19/2021
• Initial Date FDA Received: 02/10/2021
• Supplement Dates Manufacturer Received: 02/25/2021
• Supplement Dates FDA Received: 03/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR