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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 S601
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code No Clinical Signs, Symptoms or Conditions (4582)
Date of Event 01/28/2021
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The returned device was inspected and analyzed upon receipt at our (b)(6).Pacing and sensing functions were tested and the device was verified to operate as expected.Analysis did not identify any device characteristics that would have caused or contributed to the reported clinical observations.
 
Event or Problem Description
It was reported that this pacemaker system was explanted.No product allegations have been received at this time.A new system was successfully placed.No additional 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 Key11661692
Report Number2124215-2021-07944
Device Sequence Number2980401
Product Code LWP
UDI-Device Identifier00802526484469
UDI-Public00802526484469
Combination Product (Y/N)N
Initial Reporter CountryCA
PMA/510(K) Number
N970003/S096
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2012
Device Explanted Year2021
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source foreign,health professional
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 04/13/2021
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 Date05/19/2014
Device Model NumberS601
Device Catalogue NumberS601
Device Lot Number175820
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/16/2021
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 02/16/2021
Initial Report FDA Received Date04/13/2021
Patient Sequence Number1
Outcome Attributed to Adverse Event Hospitalization; Required Intervention;
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