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

Model Number DB-2202-45

Device Problems Unexpected Therapeutic Results (1631); Migration (4003)

Patient Problems Inadequate Pain Relief (2388); Encephalitis (2429); Swelling/ Edema (4577)

Event Date 05/28/2021

Event Type  Injury  

Event Description

It was reported that the patient showed swelling and signs of effectiveness attenuation and was therefore hospitalized and examined.The physician expected that swelling was caused by a device implant reaction, and noted there is a low possibility of infection.There was no intervention provided at the hospital.The physician believes that the lead migrated due to the swelling.There was suspicion of autoimmune encephalitis.A magnetic resonance imaging (mri) will be performed.The patient has not been released from the hospital.

Event Description

It was reported that the patient showed swelling and signs of effectiveness attenuation and was therefore hospitalized and examined.The physician expected that swelling was caused by a device implant reaction, and noted there is a low possibility of infection.There was no intervention provided at the hospital.The physician believes that the lead migrated due to the swelling.There was suspicion of autoimmune encephalitis.A magnetic resonance imaging (mri) will be performed.The patient has not been released from the hospital.No additional information can be obtained despite good faith efforts.

• 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: 12054494
• MDR Text Key: 258636036
• Report Number: 3006630150-2021-03177
• 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: 07/22/2021

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?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 09/05/2021
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 5172722
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/28/2021
• Initial Date FDA Received: 06/23/2021
• Supplement Dates Manufacturer Received: 07/01/2021
• Supplement Dates FDA Received: 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 62 YR