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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ALTRUA 40; IMPLANTABLE DEVICE

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BOSTON SCIENTIFIC CORPORATION ALTRUA 40; IMPLANTABLE DEVICE Back to Search Results
Model Number S403
Device Problem Use of Device Problem (1670)
Patient Problem No Code Available (3191)
Event Date 01/20/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).The returned device was inspected and analyzed upon receipt at our post market quality assurance laboratory.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 pop up message stating 'measured data test not complete.' observations.
 
Event Description
It was reported that this patient underwent an explant procedure for this dual chamber pacemaker.It is unknown if the explanted device was replaced.The device was returned to boston scientific for analysis.This report is being filled as device evaluation was completed.No additional adverse patient effects were reported.
 
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Brand Name
ALTRUA 40
Type of Device
IMPLANTABLE DEVICE
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
4100 hamline avenue north
saint paul MN 55112
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
cashel road
clonmel
EI  
Manufacturer Contact
timothy degroot
4100 hamline avenue north
saint paul, MN 55112
6515826168
MDR Report Key11042385
MDR Text Key222627035
Report Number2124215-2020-22240
Device Sequence Number1
Product Code LWP
UDI-Device Identifier00802526484445
UDI-Public00802526484445
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
N970003/S096
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/18/2020
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
Device Operator Lay User/Patient
Device Expiration Date09/07/2011
Device Model NumberS403
Device Catalogue NumberS403
Device Lot Number578316
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/09/2020
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/19/2020
Initial Date FDA Received12/18/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/09/2009
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age89 YR
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