AMPERE? RF ABLATION GENERATOR H700489

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-05 for AMPERE? RF ABLATION GENERATOR H700489 manufactured by St. Jude Medical, Inc..

Event Text Entries

[188140442] The results/method and conclusion codes along with investigation results will be provided in the final report further information regarding the event were requested but not received.
Patient Sequence No: 1, Text Type: N, H10


[188140443] Related manufacturer reference: 3008452825-2020-00090. During the procedure, the temperature of the catheter was higher than expected (approximately 90? C). The catheter also had connection issues to the ampere generator. The procedure was cancelled with no patient consequences.
Patient Sequence No: 1, Text Type: D, B5


[188741481] 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. The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2184149-2020-00032
MDR Report Key9795254
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-05
Date of Report2020-03-05
Date of Event2020-02-11
Date Mfgr Received2020-02-11
Device Manufacturer Date2017-05-01
Date Added to Maude2020-03-05
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 ContactSTEPHANIE O' SULLIVAN
Manufacturer Street5050 NATHAN LANE NORTH
Manufacturer CityPLYMOUTH MN 55442
Manufacturer CountryUS
Manufacturer Postal55442
Manufacturer Phone6517565400
Manufacturer G1ST. JUDE MEDICAL, INC. (AF-ST. PAUL)
Manufacturer StreetONE ST. JUDE MEDICAL DRIVE
Manufacturer CityST. PAUL MN 55117
Manufacturer CountryUS
Manufacturer Postal Code55117
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAMPERE? RF ABLATION GENERATOR
Generic NameGENERATOR, LESION, RADIOFREQUENCY
Product CodeGXD
Date Received2020-03-05
Model NumberH700489
Lot Number5963970
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerST. JUDE MEDICAL, INC.
Manufacturer AddressONE ST. JUDE MEDICAL DRIVE ST. PAUL MN 55117 US 55117


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-05

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