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MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-06-23 for * manufactured by *.

Event Text Entries

[15687385] According to something pt's cardiologist told family member, it sound like the wrong lead was used for pt - probably due to pt's blood condition, myeloproliferative disorder - polycythemia vera a threaded type should not have been used. Also, pt's left jugular vein was clogged so their pacemaker was installed on the right side. After this pt started forming blood clots. Apparently pt's lead was a threaded type which may have caused the clots. It caused their battery to be used extensively which would have meant having it replaced in about two years vs the normal life span of a pacemaker battery. Pt refused all further surgery which of course was the ultimate reason pt died when and how they did. Their pacemaker was a guidant #model 1283 and the lead-s - also guidant (which were the cause of the problem) were model 4463 and model 4464. Family member is not trying to cause any problems, but family member is trying to find out who chose the type of leads to be used for each situation. Family member called the mfr and the lady family member spoke to didn't know. Probably more importantly, in family member's mind, is to get the info recorded so that it becomes known. Does fda do this? If not, please get this info to the right agency. Family member has been trying to do this for years and this is their final attempt.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW1035876
MDR Report Key625663
Date Received2005-06-23
Date of Report2005-06-23
Date of Event2001-09-25
Date Added to Maude2005-08-12
Event Key0
Report Source CodeVoluntary report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationPATIENT FAMILY MEMBER OR FRIEND
Health Professional3
Initial Report to FDA0
Report to FDA0
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand Name*
Generic NamePACEMAKER LEAD
Product CodeDTA
Date Received2005-06-23
Model Number*
Catalog Number*
Lot Number*
ID Number*
Device AvailabilityN
Implant FlagY
Date Removed*
Device Sequence No1
Device Event Key615288
Manufacturer*
Manufacturer Address* * *


Patients

Patient NumberTreatmentOutcomeDate
101. Death; 2. Life Threatening 2005-06-23

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