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

Model Number DB-2202-45

Device Problems Fracture (1260); Material Twisted/Bent (2981)

Patient Problems No Code Available (3191); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/02/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the patient underwent a revision procedure to replace a fractured lead that was slightly bent.Following the procedure the patient was noted to be doing well.

Manufacturer Narrative

Device technical analysis: the returned lead was analyzed and revealed the distal tip of the lead is slightly curved.However, the distal end straightness specification was checked, and was confirmed to be still within the specification.The lead has a displacement of less than 1.3 mm relative to the vertical.Investigation conclusion: the investigation concluded that the reported event of the lead being slightly bent was confirmed, however the lead was confirmed to be within the specification, and exhibits normal characteristics and no problem was detected.

Event Description

It was reported that the patient underwent a revision procedure to replace a fractured lead that was slightly bent.Following the procedure the patient was noted to be doing well.

Event Description

It was reported that the patient underwent a revision procedure to replace a fractured lead that was slightly bent.Following the procedure the patient was noted to be doing well.

Manufacturer Narrative

Correction to block h10 - device analysis conclusion device technical analysis: the returned lead was analyzed and revealed the distal tip of the lead is slightly curved.However, the distal end straightness specification was checked, and was confirmed to be still within the specification.The lead has a displacement of less than 1.3 mm relative to the vertical.Investigation conclusion: the investigation concluded that the reported event of the lead being fractured couldn't be confirmed.Visual inspection of the lead revealed that it is not fractured.However the reported event of lead being slightly bent was confirmed yet engineers determined it to be within the specification, and exhibits normal characteristics and no problem was detected.

• 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: 11038602
• MDR Text Key: 222394190
• Report Number: 3006630150-2020-06270
• 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,Followup
• Report Date: 02/19/2021

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: Lay User/Patient
• Device Expiration Date: 06/16/2022
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7074076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 12/18/2020
• Supplement Dates Manufacturer Received: 02/02/2021; 02/19/2021
• Supplement Dates FDA Received: 02/17/2021; 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention