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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 S602
Device Problems Communication or Transmission Problem (2896); Interrogation Problem (4017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/03/2022
Event Type  malfunction  
Event Description
It was reported that during a routine device check, this pacemaker was unable to be interrogated.Appropriate magnet response was verified.The patient will return to the clinic in 1 week for a recheck.No adverse patient effects were reported.The device remains implanted.
 
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Brand Name
ALTRUA 60
Type of Device
IMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
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 Key14682945
MDR Text Key293923111
Report Number2124215-2022-20990
Device Sequence Number1
Product Code LWP
UDI-Device Identifier00802526484476
UDI-Public00802526484476
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
N970003/S096
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 06/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Expiration Date11/30/2012
Device Model NumberS602
Device Catalogue NumberS602
Device Lot Number770922
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/03/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/02/2010
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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