MEDTRONIC UNIPOLAR CONNECTOR 4557M - 53 CM

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-07-29 for MEDTRONIC UNIPOLAR CONNECTOR 4557M - 53 CM manufactured by Medtronic, Inc..

Event Text Entries

[12801] Dual chamber rate responsive permanent pacemaker was inserted on 5/29/94. In the or, the pacemaker was noted to be functioning well but the atrial output did not seem to capture the atrium. A chest x-ray was obtained and confirmed proper lead placement prior to the completion of the surgery. The atrium could not be aced with voltages up to 8 volts, and no current could be measured. The atrium also appeared to be electrically insert. 18 hours s/p pacemaker implantation, the patient developed bradycardia and arrested. The arrest was believed to be due to the pacemaker's failure to cature. The patient received cpr and was successfully resuscitated. The pacemaker was subsequently interrogated and reprogrammed. The patient was discharged home without any long term complications.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number18099
MDR Report Key18099
Date Received1994-07-29
Date of Report1994-06-20
Date of Event1994-05-30
Date Facility Aware1994-06-13
Report Date1994-06-20
Date Reported to Mfgr1994-06-21
Date Added to Maude1994-12-01
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameMEDTRONIC UNIPOLAR CONNECTOR
Generic NamePACEMAKER LEAD
Product CodeDTA
Date Received1994-07-29
Model Number4557M - 53 CM
Device Expiration Date1996-03-17
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age1 DAY
Implant FlagY
Date RemovedB
Device Sequence No1
Device Event Key18027
ManufacturerMEDTRONIC, INC.
Manufacturer AddressMINNEAPOLIS MN 55432 US


Patients

Patient NumberTreatmentOutcomeDate
101. Life Threatening; 2. Required No Informationntervention 1994-07-29

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