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

Model Number DB-1232

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

Patient Problem Pneumonia (2011)

Event Date 04/23/2021

Event Type  Injury  

Event Description

It was reported that the patient, that is enrolled in the (b)(6) study, developed pneumonia two days post implant.It was indicated that no action was take to resolve the event.It was also noted that the pneumonia was assesses a having a possible relationship to the procedure and not related to the device.

Event Description

It was reported that the patient, that is enrolled in the cartesia extend 3d study, developed pneumonia two days post implant.It was indicated that no action was take to resolve the event.It was also noted that the pneumonia was assessed as having a possible relationship to the procedure and not related to the device.Additional informaiton was received that the event of pneumonia resolved.

Event Description

It was reported that the patient, that is enrolled in the cartesia extend 3d study, developed pneumonia two days post implant.It was indicated that no action was taken to resolve the event.It was also noted that the pneumonia was assessed as having a possible relationship to the procedure and not related to the device.Additional information was received that the patient was given antibiotic therapy and the event resolved.

Manufacturer Narrative

Correction to field d1: brand name.

• 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 Contact: talar tahmasian ; 25155 rye canyon loop; valencia, CA 91355 ; 6619494863
• MDR Report Key: 11866770
• MDR Text Key: 252318631
• Report Number: 3006630150-2021-02309
• Device Sequence Number: 1
• Product Code: NHL
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 01/24/2022

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-1232
• Device Catalogue Number: DB-1232
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2021
• Initial Date FDA Received: 05/21/2021
• Supplement Dates Manufacturer Received: 12/02/2021; 12/30/2021
• Supplement Dates FDA Received: 12/23/2021; 01/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other; Hospitalization
• Patient Age: 66 YR
• Patient Sex: Male