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

Model Number DB-2203-30C

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

Patient Problem Cerebral Edema (4403)

Event Date 07/22/2022

Event Type  Injury  

Event Description

It was reported that a computed tomography scan revealed that the clinical study patient experienced a serious adverse event of cerebral edema around the left lead with moderate severity.The patient was treated with medication and experienced a prolonged hospitalization.Further hospitalization was uneventful and further action was not required due to the patients overall improvement.The event was resolved and the patient was discharged.It was assessed that this event was possibly related to the device.

Event Description

It was reported that a computed tomography scan revealed that the clinical study patient experienced a serious adverse event of cerebral edema around the left lead with moderate severity.The patient was treated with medication and experienced a prolonged hospitalization.Further hospitalization was uneventful and further action was not required due to the patient's overall improvement.The event was resolved and the patient was discharged.It was assessed that this event was possibly related to the device.Additional information was received that the event of cerebral edema around the left lead was mild in severity.

• 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: 15279934
• MDR Text Key: 298454664
• Report Number: 3006630150-2022-04235
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/16/2022

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: 02/18/2023
• Device Model Number: DB-2203-30C
• Device Catalogue Number: DB-2203-30C
• Device Lot Number: 5000526
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2022
• Initial Date FDA Received: 08/23/2022
• Supplement Dates Manufacturer Received: 08/24/2022
• Supplement Dates FDA Received: 09/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/18/2021
• 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