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

[187335867] Concomitant medical products: product id: 3889-28, lot# va1tb8r, implanted: (b)(6) 2018, explanted: (b)(6) 2020, product type: lead. Explant date of 3889-28 lead, lot number va1tb8r was omitted in last report. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[187646792] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[187646793] Additional information was received from the manufacturer representative who stated that the device was replaced on (b)(6) 2020 and that the cause of the device not working was unknown as the patient? S perception was it was? Pulled apart?. The physician inspected the removed lead and said it looked intact and did not notice any pulling apart, breakage, no further complications noted or anticipated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004209178-2020-06482
MDR Report Key9908857
Report SourceCOMPANY REPRESENTATIVE,CONSUM
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2019-11-01
Date Mfgr Received2020-03-25
Device Manufacturer Date2018-06-09
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
Device Expiration Date2019-11-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
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
101. Required No Informationntervention 2020-03-31

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