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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 2 DR; IMPLANTABLE DEVICE
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BOSTON SCIENTIFIC CORPORATION ALTRUA 2 DR; IMPLANTABLE DEVICE Back to Search Results
Model Number S702
Medical Device Problem Code Premature Discharge of Battery (1057)
Health Effect - Clinical Code Insufficient Information (4580)
Date of Event 12/07/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
No further information is available at this time.If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that this pacemaker exhibited premature battery depletion as the elective replacement indicator was triggered approximately one and a half years after implant.Currently, this device remains in service.No adverse patient effects were reported.
 
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Brand Name
ALTRUA 2 DR
Common Device Name
IMPLANTABLE DEVICE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key11290121
Report Number2124215-2020-29301
Device Sequence Number3842859
Product Code LWP
UDI-Device Identifier00802526559341
UDI-Public00802526559341
Combination Product (Y/N)N
Initial Reporter CountryRS
PMA/510(K) Number
N970003/S167
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 02/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device No Information
Device Expiration Date01/21/2021
Device Model NumberS702
Device Catalogue NumberS702
Device Lot Number705201
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/07/2020
Initial Report FDA Received Date02/05/2021
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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