MEDTRONIC INTERSTIM ICON

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-11-09 for MEDTRONIC INTERSTIM ICON manufactured by Medtronic Neuromodulation.

Event Text Entries

[91872202] Patient states that she began experiencing a shocking feeling on the left foot and also had two of her toes curling involuntarily. She then states that in (b)(6), she had to have surgery in order to replace the battery for the interstim due to an electrical short. The battery was said to last 3-5 years yet, failed to last even 1 year. She states that recently she had surgery on (b)(6), to treat a bone spur in her left foot as a result of the interstim.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report NumberMW5073208
MDR Report Key7013660
Date Received2017-11-09
Date of Report2017-11-08
Date of Event2016-01-04
Date Added to Maude2017-11-09
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
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameMEDTRONIC INTERSTIM ICON
Generic NameSTIMULATOR, ELECTRICAL, IMPLANTABLE
Product CodeKPI
Date Received2017-11-09
Device Availability*
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC NEUROMODULATION


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Other; 3. Required No Informationntervention; 4. Deathisabilit 2017-11-09

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