INTERSTIM II 3058

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,consum report with the FDA on 2020-03-31 for INTERSTIM II 3058 manufactured by Medtronic Puerto Rico Operations Co..

Event Text Entries

[185960291] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185960292] Information was received from a consumer via a manufacturer representative regarding their implantable neurostimulator (ins) for gastrointestinal/pelvic floor. It was reported that they had increased pain at the ins site. They had burning at the ins site when a different ins was on. They thought that the ins caused issues with their other ins. When both devices were on their nerve pain increased and doubled. No further device issue alleged / identified. No further patient symptoms or complications were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004209178-2020-06475
MDR Report Key9908085
Report SourceCOMPANY REPRESENTATIVE,CONSUM
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-02-19
Date Mfgr Received2020-03-20
Device Manufacturer Date2020-01-21
Date Added to Maude2020-03-31
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 ContactLISA WOODWARD CLARK
Manufacturer Street7000 CENTRAL AVENUE NE RCW215
Manufacturer CityMINNEAPOLIS MN 55432
Manufacturer CountryUS
Manufacturer Postal55432
Manufacturer Phone7635263920
Manufacturer G1MEDTRONIC PUERTO RICO OPERATIONS CO.
Manufacturer StreetROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK
Manufacturer CityJUNCOS PR 00777
Manufacturer CountryUS
Manufacturer Postal Code00777
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINTERSTIM II
Generic NameSTIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
Product CodeEZW
Date Received2020-03-31
Model Number3058
Catalog Number3058
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC PUERTO RICO OPERATIONS CO.
Manufacturer AddressROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK JUNCOS PR 00777 US 00777


Patients

Patient NumberTreatmentOutcomeDate
10 2020-03-31

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