SURESCAN 97714

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-31 for SURESCAN 97714 manufactured by Medtronic Puerto Rico Operations Co..

Event Text Entries

[185961396] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185961397] Information was received from the manufacturer's representative regarding a patient who was implanted with a neurostimulator for spinal cord stimulation. It was reported that the patient was currently in the hospital, unrelated to the device or therapy. The rep reported he did not know if the device was dead; possible overdischarge. Hcp wanted to perform an mri of the brain. Pss reviewed that discharged ins was considered off. No symptoms reported. Additional information was received from a rep. The rep reported that an overdischarge was confirmed. The cause was that the patient just stopped charging her device. The rep reported that there was no desire from the patient nor the clinic on any follow up to resolve the issue. The battery remained in overdischarge. There were no plans on the patient? S part to revive the battery. No further complications were reported.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004209178-2020-06479
MDR Report Key9908294
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-03-31
Date of Report2020-03-31
Date Mfgr Received2020-03-11
Device Manufacturer Date2015-03-23
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 NameSURESCAN
Generic NameSTIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
Product CodeLGW
Date Received2020-03-31
Model Number97714
Catalog Number97714
Device Expiration Date2016-02-14
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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