ACCOLADE MRI DR L311

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-31 for ACCOLADE MRI DR L311 manufactured by Boston Scientific Corporation.

Event Text Entries

[185884144] (b)(4). Cardiopulmonary resuscitation, performed. Records indicate this device remained implant. As no further information concerning this report is expected, our investigation is complete. This investigation will be updated should further information be provided.
Patient Sequence No: 1, Text Type: N, H10


[185884145] It was reported that following a lotus edge valve implant procedure, this patient became indicated for placement of a pacemaker. This device was successfully implanted and the pocket was closed without complication. At the end of the procedure the patient complained of back pain, dry mouth and her blood pressure dropped. The patient then went into cardiac arrest and cardiopulmonary resuscitation was performed. The patient's ventricular function was at 15% and patient was on a ventilator and non responsive. The patient was transferred to the intensive care unit where the their blood pressure dropped again. The patient was assessed and it was determined that the patient may have sustained brain damage. The family elected to remove ventilator support and the patient passed away within 10 minutes.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2124215-2020-06589
MDR Report Key9907995
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-04
Date Mfgr Received2020-03-04
Device Manufacturer Date2019-05-24
Date Added to Maude2020-03-31
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactTIMOTHY DEGROOT
Manufacturer Street4100 HAMLINE AVENUE NORTH
Manufacturer CitySAINT PAUL MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone6515826168
Manufacturer G1BOSTON SCIENTIFIC CORPORATION
Manufacturer StreetCASHEL ROAD
Manufacturer CityCLONMEL
Manufacturer CountryEI
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameACCOLADE MRI DR
Generic NameIMPLANTABLE PULSE GENERATOR, PACEMAKER (NON-CRT)
Product CodeLWP
Date Received2020-03-31
Model NumberL311
Catalog NumberL311
Lot Number426977
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBOSTON SCIENTIFIC CORPORATION
Manufacturer Address4100 HAMLINE AVENUE NORTH SAINT PAUL MN 55112 US 55112


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2020-03-31

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