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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 20; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
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BOSTON SCIENTIFIC CORPORATION ALTRUA 20; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) Back to Search Results
Model Number S208
Medical Device Problem Code Premature Discharge of Battery (1057)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/31/2019
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This product was not returned back from the field for analysis.As no further information regarding this event is expected, our investigation is complete.This report will be updated should additional information be provided.
 
Event or Problem Description
It was reported that the battery of this pacemaker had prematurely depleted.Surgical intervention was performed and the pacemaker was explanted and replaced.No additional adverse patient effects were reported.
 
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Brand Name
ALTRUA 20
Common Device Name
IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
MDR Report Key9225684
Report Number2124215-2019-21993
Device Sequence Number1892530
Product Code LWP
UDI-Device Identifier00802526484421
UDI-Public00802526484421
Combination Product (Y/N)N
Initial Reporter CountryIN
PMA/510(K) Number
N970003/S106
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Device Explanted Year2019
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 10/23/2019
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
Operator of Device Lay User/Patient
Device Expiration Date05/12/2013
Device Model NumberS208
Device Catalogue NumberS208
Device Lot Number597174
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/31/2019
Initial Report FDA Received Date10/23/2019
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Life Threatening;
Patient Age58 YR
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