ALTRUA PACEMAKER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-18 for ALTRUA PACEMAKER manufactured by Boston Scientific Corporation.

Event Text Entries

[139300139] Biventricular lead extraction and replacement with a new lead.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5084989
MDR Report Key8432548
Date Received2019-03-18
Date of Report2019-03-14
Date of Event2019-02-28
Date Added to Maude2019-03-19
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Sequence Number: 1

Brand NameALTRUA PACEMAKER
Generic NamePACEMAKER / ICD / CRT NON-IMPLANTABLE / COMPONENTS
Product CodeOSR
Date Received2019-03-18
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer AddressMARLBOROUGH MA 01752 US 01752

Device Sequence Number: 2

Brand NameCRDM NON-DEFIB LEAD DEXTRUS
Generic NameDRUG-ELUTING PERMANENT RIGHT VENTRICULAR (RV) OR RIGHT ATRIAL (RA) PACEMAKER ELE
Product CodeNVN
Date Received2019-03-18
Model Number4136
Catalog Number358754
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No2
Device Event Key0
ManufacturerBIOTRONIK INC.


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-03-18

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