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 Hemorrhage/Bleeding (1888); Balance Problems (4401); Speech Disorder (4415)

Event Date 06/01/2023

Event Type  Injury  

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: dbs-linear leads, upn: m365db2202450, model: db-2202-45, serial: (b)(6), batch: 7105287.

Event Description

It was reported that the patient experienced difficulties speaking, balance problems and partial facial paralysis following a deep brain stimulation (dbs) lead implant procedure.The patient was hospitalized, and a computed tomography (ct) image taken did not reveal any anomalies, however a magnetic resonance image (mri) revealed a minor bleed around the left dbs lead.The physician assessed the minor hemorrhage caused the patient's medical issues; however, the patient did not require additional medical intervention.The patient did well, however, continues to be monitored.

Manufacturer Narrative

Additional suspect medical device components involved in the event: product family: dbs-linear leads upn: m365db2202450 model: db-2202-45 serial/batch: 7105287.

Event Description

It was reported that the patient experienced difficulties speaking, balance problems and partial facial paralysis following a deep brain stimulation (dbs) lead implant procedure.The patient was hospitalized, and a computed tomography (ct) image taken did not reveal any anomalies, however a magnetic resonance image (mri) revealed a minor bleed around the left dbs lead.The physician assessed the minor hemorrhage caused the patient's medical issues; however, the patient did not require additional medical intervention.The patient did well, however, continues to be monitored.Additional information was received that the patient has almost made a full recovery.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; road 698, lot no. 12; dorado PR 00646 -260; * 00646-2602
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 17332378
• MDR Text Key: 319183801
• Report Number: 3006630150-2023-04156
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729905288
• UDI-Public: 08714729905288
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/17/2023

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 Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7104560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/26/2023
• Initial Date FDA Received: 07/17/2023
• Supplement Dates Manufacturer Received: 07/23/2023
• Supplement Dates FDA Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/25/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 73 YR
• Patient Sex: Male