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

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

Patient Problems Emotional Changes (1831); Hematoma (1884); Muscle Weakness (1967); Dyskinesia (2363); Sleep Dysfunction (2517); Speech Disorder (4415); Cramp(s) /Muscle Spasm(s) (4521); Swelling/ Edema (4577)

Event Date 04/12/2021

Event Type  Injury  

Event Description

It was reported that literature reviews were completed and 52 product related adverse events were attributed to the cartesia directional lead.The patients experienced apathy (15), dysarthria (13), dyskinesia (15), and pyramidal adverse effects (5).In addition, 4 patient experienced symptomatic idiopathic delayed-onset edema with drowsiness (3), paresis (1), and apathy (1).Of the latter 4 patients, all recovered with 2 of those patients given cortisone treatment.No identifying information was available but the devices appeared to have been manufactured by boston scientific.No additional information was provided.

• Type of Device: STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
• 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: 11794402
• MDR Text Key: 249695199
• Report Number: 3006630150-2021-01999
• Device Sequence Number: 1
• Product Code: MHY
• 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: company representative,litera
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/07/2021

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/12/2021
• Initial Date FDA Received: 05/07/2021
• 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): Required Intervention