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

Model Number DB-1232

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

Patient Problems Cognitive Changes (2551); Cerebral Edema (4403); Insufficient Information (4580)

Event Date 01/07/2022

Event Type  Injury  

Event Description

It was reported that the deep brain stimulator clinical patient, (b)(4) study, experienced a non-serious adverse event of a few short lasting episodes of mild apraxia.The episodes started ten days after the initial implant procedure.The patient was seen in the emergency room and was hospitalized.The patient was also given medication.The event is ongoing.It was assessed that the event is possibly related to the implant procedure, and not related to the device.

Event Description

It was reported that the deep brain stimulator clinical patient, (b)(6) cartesia extend 3d study, experienced a non-serious adverse event of a few short lasting episodes of mild apraxia.The episodes started ten days after the initial implant procedure.The patient was seen in the emergency room and was hospitalized.The patient was also given medication.The event is ongoing.It was assessed that the event is possibly related to the implant procedure, and not related to the device.Additional information was received that the patients symptoms included pouring coffee into cups, however used a milk carton, preparing tea with extra items on the table like a box of eggs, and not knowing how to pick up the telephone.A computerized tomography scan showed small edema, however the small amount does not explain the patients symptoms.The event is ongoing.

Event Description

It was reported that the deep brain stimulator clinical patient, (b)(6) cartesia extend 3d study, experienced a non-serious adverse event of a few short lasting episodes of mild apraxia.The episodes started ten days after the initial implant procedure.The patient was seen in the emergency room and was hospitalized.The patient was also given medication.The event is ongoing.It was assessed that the event is possibly related to the implant procedure, and not related to the device.Additional information was received that the patient symptoms included pouring coffee into cups, however used a milk carton, preparing tea with extra items on the table like a box of eggs, and not knowing how to pick up the telephone.A computerized tomography scan showed small edema, however the small amount does not explain the patients symptoms.The event is ongoing.Additional information was received that the patient was seen in the emergency room but was not was hospitalized.

Event Description

It was reported that the deep brain stimulator clinical patient experienced a non-serious adverse event of a few short lasting episodes of mild apraxia.The episodes started ten days after the initial implant procedure.The patient was seen in the emergency room and was hospitalized.The patient was also given medication.The event is ongoing.It was assessed that the event is possibly related to the implant procedure, and not related to the device.Additional information was received that the patients symptoms included pouring coffee into cups, however used a milk carton, preparing tea with extra items on the table like a box of eggs, and not knowing how to pick up the telephone.A computerized tomography scan showed small edema, however the small amount does not explain the patients symptoms.The event is ongoing.Additional information was received that the patient was seen in the emergency room but was not hospitalized.Additional information was received that the event resolved.

• Brand Name: VERCISE GENUS¿
• 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; cashel road; clonmel ; EI
• Manufacturer Contact: erik sherburne ; 25155 rye canyon loop; valencia, CA 91355 ; 7632920920
• MDR Report Key: 13476367
• MDR Text Key: 285214081
• Report Number: 3006630150-2022-00391
• Device Sequence Number: 1
• Product Code: NHL
• UDI-Device Identifier: 08714729985051
• UDI-Public: 08714729985051
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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,Followup
• Report Date: 11/07/2022

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 Expiration Date: 01/10/2023
• Device Model Number: DB-1232
• Device Catalogue Number: DB-1232
• Device Lot Number: 501796
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/11/2022
• Initial Date FDA Received: 02/07/2022
• Supplement Dates Manufacturer Received: 02/21/2022; 04/11/2022; 10/20/2022
• Supplement Dates FDA Received: 03/21/2022; 05/07/2022; 11/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2021
• 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): Required Intervention
• Patient Sex: Male