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

Model Number DB-2202-45

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); No Code Available (3191)

Event Date 12/12/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).It is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device cannot be completed.A review of the device history records will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported that a patient implanted with a db-2202-45 experience mild left peri-lead edema that was assessed by the physician to be mild in severity.Device was reprogrammed and the patient was treated with medication.It was reported that the event is resolving; and that the physician assessed this event to have a causal relationship to the procedure, unlikely related to stimulation, and not related to device hardware.

Event Description

It was reported that a patient implanted with a db-2202-45 experience mild left peri-lead edema that was assessed by the physician to be mild in severity.Device was reprogrammed and the patient was treated with medication.It was reported that the event is resolving; and that the physician assessed this event to have a causal relationship to the procedure, unlikely related to stimulation, and not related to device hardware.

Manufacturer Narrative

Additional information was received indicating the patient was asymptomatic when peri-lead edema was noted on the proximal end.A head ct was performed and showed that the edema that surrounded the transfrontal trajectory of the left lead has resolved.

• 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: 9599281
• MDR Text Key: 175448394
• Report Number: 3006630150-2020-00079
• 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: 02/18/2020

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: 10/22/2021
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 5180069
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/20/2019
• Initial Date FDA Received: 01/16/2020
• Supplement Dates Manufacturer Received: 01/28/2020
• Supplement Dates FDA Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention