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

Model Number DB-2202-45

Device Problems Low impedance (2285); Structural Problem (2506)

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

Event Date 04/19/2021

Event Type  Injury  

Event Description

It was reported that low impedances were observed after connecting to the implantable pulse generator (ipg) during a stage 2 deep brain stimulation (dbs) procedure.Attempts to reposition the lead did not resolve the event.The physician assessed that the lead may have been bent at the distal end, but this was not confirmed.The procedure was stopped to prevent any potential additional damage to the lead and remains implanted.No further information has been obtained despite good faith efforts.

Event Description

It was reported that low impedances were observed after connecting to the implantable pulse generator (ipg) during a stage 2 deep brain stimulation (dbs) procedure.Attempts to reposition the lead did not resolve the event.The physician assessed that the lead may have been bent at the distal end, but this was not confirmed.The procedure was stopped to prevent any potential additional damage to the lead and remains implanted.No further information has been obtained despite good faith efforts.Additional information received clarified that repositioning the lead meant disconnecting and reconnecting the lead into the lead extension.Post-operative reprogramming went well, and no further course of action is needed.

• 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: 11829080
• MDR Text Key: 250856821
• Report Number: 3006630150-2021-02139
• 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: 06/02/2021

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: Health Professional
• Device Expiration Date: 03/22/2023
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7080918
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/19/2021
• Initial Date FDA Received: 05/14/2021
• Supplement Dates Manufacturer Received: 05/14/2021
• Supplement Dates FDA Received: 06/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 69 YR