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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 60; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
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BOSTON SCIENTIFIC CORPORATION ALTRUA 60; IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT) Back to Search Results
Model Number S603
Medical Device Problem Code Defective Device (2588)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 06/02/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
This product has not been returned for analysis.This report will be updated should additional information become available or if analysis is completed.
 
Event or Problem Description
It was reported that this pacemaker device has malfunctioned.The health care provider (hcp) requested for a boston scientific representative to check the device.Additionally, the device was already explanted and replaced with a new one.No adverse patient effects were reported.
 
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Brand Name
ALTRUA 60
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 Key12271711
Report Number2124215-2021-22455
Device Sequence Number4371012
Product Code LWP
UDI-Device Identifier00802526484483
UDI-Public00802526484483
Combination Product (Y/N)N
Initial Reporter StatePR
Initial Reporter CountryUS
PMA/510(K) Number
N970003/S096
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2011
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source health professional
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 08/03/2021
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? Yes
Operator of Device Lay User/Patient
Device Expiration Date07/08/2013
Device Model NumberS603
Device Catalogue NumberS603
Device Lot Number842630
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 06/02/2021
Initial Report FDA Received Date08/03/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
Patient Age59 YR
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