RESUME ILC LEAD 3986ILC NA

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 1998-06-15 for RESUME ILC LEAD 3986ILC NA manufactured by Medtronic Inc..

Event Text Entries

[109081] Report received with explanted devices stating that the pt was experiencing a "jolting" feeling on low amplitudes, and that there was a question of a possible lead fracture or electrical leak. It was also noted that the physician had "trimmed both leads" prior to implantation, against the advice of the manufacturer's rep present at implantation. Device analysis is ongoing as of the date of this report.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2182207-1998-00156
MDR Report Key173216
Report Source05
Date Received1998-06-15
Date of Report1998-05-05
Date of Event1998-03-23
Date Mfgr Received1998-05-05
Device Manufacturer Date1997-12-01
Date Added to Maude1998-06-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
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 Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameRESUME ILC LEAD
Generic NameSURGICAL EPIDURAL LEAD
Product CodeLHG
Date Received1998-06-15
Returned To Mfg1998-05-05
Model Number3986ILC
Catalog NumberNA
Lot NumberN23199
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Age2.5 MO
Device Eval'ed by MfgrY
Implant FlagY
Date RemovedV
Device Sequence No1
Device Event Key168424
ManufacturerMEDTRONIC INC.
Manufacturer Address800 53RD AVE NE MINNEAPOLIS MN 55421 US
Baseline Brand NameRESUME ILC LEAD
Baseline Generic NameSURGICAL EPIDURAL LEAD
Baseline Model No3986ILC
Baseline Catalog NoNA
Baseline IDNA
Baseline Device FamilySTIM RESUME ILC LEAD
Baseline Shelf Life ContainedY
Baseline Shelf Life [Months]48
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK913934
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Other 1998-06-15

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.