ASSURITY MRI PM2272

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 ASSURITY MRI PM2272 manufactured by St. Jude Medical, Inc.(crm-sunnyvale).

Event Text Entries

[185933965] The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10


[185933966] Related manufacturer reference number: 2938836-2020-02373; 2938836-2020-02374. It was reported that during in clinic check, low impedance was observed on the right atrial and ventricular leads. The physician also alleged malfunction on the pacemaker. The noise was not reproducible but currently, the clinic still received impedance alerts on merlin. Net. The patient was stable and will continue to be monitored since he was not pacemaker dependent.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2938836-2020-02375
MDR Report Key9908677
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-02-26
Date Mfgr Received2020-03-12
Device Manufacturer Date2019-03-09
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
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactELIZABETH BOLTZ
Manufacturer Street15900 VALLEY VIEW COURT
Manufacturer CitySYLMAR CA 91342
Manufacturer CountryUS
Manufacturer Postal91342
Manufacturer G1ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
Manufacturer Street645 ALMANOR AVENUE
Manufacturer CitySUNNYVALE CA 94085
Manufacturer CountryUS
Manufacturer Postal Code94085
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameASSURITY MRI
Generic NameIMPLANTABLE PACEMAKER PULSE GENERATOR
Product CodeLWP
Date Received2020-03-31
Model NumberPM2272
Catalog NumberPM2272
Lot NumberA000076048
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
Manufacturer Address645 ALMANOR AVENUE SUNNYVALE CA 94085 US 94085


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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