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 Unspecified Musculoskeletal problem (4535); Insufficient Information (4580)

Event Date 08/11/2021

Event Type  Injury  

Manufacturer Narrative

Age or date of birth: year of birth (b)(6) exact date is unknown.

Event Description

It was reported that the clinical study, (b)(6) patient experienced a serious adverse event of recurred torticollis which was severe.The patient was admitted four days later and underwent a lead replacement procedure three days after the admission.The patient was discharged nine days after the procedure.The relationship to procedure was reported as causal relationship, the relationship to the device itself was reported as not related, and the relationship to stimulation was reported as unlikely.

Event Description

It was reported that the patient enrolled in the a4012 clinical study experienced a serious adverse event of recurred torticollis which was severe.Imaging was performed following the initial implant, indicating that the lead was placed in the incorrect location.The patient was admitted four days later and underwent a lead replacement procedure three days after the admission.The patient was discharged nine days after the procedure, and the event was resolved, and the patient condition was improved.The relationship to the procedure was reported as having a causal relationship, the relationship to the device itself was reported as not related, and the relationship to stimulation was reported as unlikely.The device will not be returned as it was discarded.

Manufacturer Narrative

Block a2 date of birth: year of birth 1979, exact date is unknown.

• 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: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 12611867
• MDR Text Key: 276124189
• Report Number: 3006630150-2021-05691
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729905288
• UDI-Public: 08714729905288
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P150031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/04/2021

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: 05/04/2023
• Device Model Number: DB-2202-45
• Device Catalogue Number: DB-2202-45
• Device Lot Number: 7081751
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2021
• Initial Date FDA Received: 10/11/2021
• Supplement Dates Manufacturer Received: 11/09/2021
• Supplement Dates FDA Received: 12/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2021
• 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; Required Intervention
• Patient Sex: Female