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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DEEP BRAIN STIMULATION (DBS) SYSTEM; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
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BOSTON SCIENTIFIC CORPORATION DEEP BRAIN STIMULATION (DBS) SYSTEM; STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS Back to Search Results
Health Effect - Clinical Codes Failure of Implant (1924); Post Operative Wound Infection (2446)
Date of Event 02/01/2024
Type of Reportable Event Serious Injury
Event or Problem Description
Caller stated their family member was implanted with boston scientific dbs system for epilepsy in (b)(6) 2024 but had an infection.Caller stated they had heard that boston scientific had a recall related to infections and at the hospital where the patient was implanted, 2 of the 5 patients had an infection.Caller stated their family member was treated with antibiotics and had a lead revision due to the lead being infected.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).
 
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Brand Name
DEEP BRAIN STIMULATION (DBS) SYSTEM
Common Device Name
STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN SYMPTOMS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
MDR Report Key20565851
Report NumberMW5161833
Device Sequence Number12039971
Product Code NHL
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2024
Reporter Type Voluntary
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 10/22/2024
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
Initial Date Received by Manufacturer Not provided
Initial Report FDA Received Date10/28/2024
Patient Sequence Number1
Patient SexUnknown
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