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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC NEUROMODULATION; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
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BOSTON SCIENTIFIC NEUROMODULATION; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR Back to Search Results
Device Problem Unexpected Therapeutic Results (1631)
Patient Problem Insufficient Information (4580)
Event Date 07/07/2023
Event Type  Injury  
Manufacturer Narrative
Additional suspect medical device component involved in the event: product family: unknown dbs lead, upn: n/i, model: n/i, serial: (b)(6), batch: n/i.
 
Event Description
It was reported that when stimulation was turned on, the deep brain stimulation (dbs) patient experienced no benefit and unspecified side effects.The physician assessed the lead was misplaced.The patient underwent a revision procedure to reposition the lead and the patient did well postoperatively.
 
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Type of Device
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Manufacturer (Section D)
BOSTON SCIENTIFIC NEUROMODULATION
25155 rye canyon loop
valencia CA 91355
Manufacturer Contact
erik sherburne
25155 rye canyon loop
valencia, CA 91355
7632920920
MDR Report Key18297772
MDR Text Key330111802
Report Number3006630150-2023-07735
Device Sequence Number1
Product Code MHY
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
P150031
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 12/08/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2023
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
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/13/2023
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 Number1
Patient Outcome(s) Required Intervention;
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