INTELLIS 97715

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2020-03-31 for INTELLIS 97715 manufactured by Medtronic Puerto Rico Operations Co..

Event Text Entries

[185962120] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185962121] Information was received from a consumer regarding a patient with an implantable neurostimulator (ins). It was reported that the patient? S ins was not working at all, which was clarified further to mean the ins was not providing them relief. The patient stated that the ins was not stopping the spasms and the ins was shocking them like crazy. The patient noted trying group a, b and c that they had available. The patient stated that the last time they charged the ins and stopped using the ins was this month, (b)(6) 2020. The patient was calling in for assistance with accessing mri mode. Patient services began walking the patient through accessing mri mode when the patient saw the? No device found? Error message on the controller. Patient services stated that the ins battery was dead and they hadn? T charged the ins. Patient services had the patient connect the recharger to the controller and start an ins charging session. The patient confirmed seeing recharging with excellent recharge quality. Patient services reviewed that the ins must be charged to at least 30 percent in order the ins to be turned on and access mri mode. The patient would call back once the ins was charged enough to be walked through accessing mri mode. The event occurred in (b)(6) 2020. No further complications were reported/anticipated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004209178-2020-06477
MDR Report Key9908163
Report SourceCONSUMER
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-01
Date Mfgr Received2020-03-25
Device Manufacturer Date2019-01-21
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 NameINTELLIS
Generic NameSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Product CodeLGW
Date Received2020-03-31
Model Number97715
Catalog Number97715
Device Expiration Date2020-01-14
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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