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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION; ADAPTER
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BOSTON SCIENTIFIC CORPORATION; ADAPTER Back to Search Results
Model Number 6931
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Unspecified Infection (1930); Sepsis (2067)
Date of Event 03/10/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that this adapter lead was part of a system revision due to infection and sepsis.There were no additional adverse patient effects reported.The adapter lead remains in service.
 
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Brand Name
NA
Common Device Name
ADAPTER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key11788343
Report Number2124215-2021-12914
Device Sequence Number17148162
Product Code LWS
UDI-Device Identifier00802526067884
UDI-Public00802526067884
Combination Product (Y/N)N
Initial Reporter StateMN
Initial Reporter CountryUS
PMA/510(K) Number
P910073/S018
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2004
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 05/06/2021
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? No
Operator of Device Lay User/Patient
Device Expiration Date12/31/2005
Device Model Number6931
Device Catalogue Number6931
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/10/2021
Initial Report FDA Received Date05/06/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age55 YR
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