SURESCAN 97714

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 SURESCAN 97714 manufactured by Medtronic Med Rel Medtronic Puerto Rico.

Event Text Entries

[185970504] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185970505] Information was received from a patient with an implantable neurostimulator (ins). It was reported that when the patient would get up from sitting, they would get a shock right above their ins. The patient stated that their ins location is near their hip, within four to five inches. The patient reported that when they would bend a certain way, they would experience a jab feeling, almost like a wire was loose and jabbing into their skin. It was confirmed by the patient that there were no falls or traumas that may have led or contributed to the issue and has not changed their stimulation. It was noted that the issue had been going on for about two weeks. It was recommended that the patient meet with their healthcare provider (hcp) to check their ins. No further complications were reported/anticipated. Indication for use is non-malignant pain.
Patient Sequence No: 1, Text Type: D, B5


[188933293] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[188933294] Additional information received from the consumer reported that the issue had been gradually coming on. The patient stated that she would occasionally get severe pain around the battery. The patient had tried turning off stimulation to see if it was something else but the shocking only happened when the stimulator was on. The issue was not resolved and the patient noted that the battery was 7 years old and they would go with it until it died because they had been denied a replacement by their insurance.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004209178-2020-06480
MDR Report Key9908444
Report SourceCONSUMER
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-04
Date Mfgr Received2020-03-18
Device Manufacturer Date2013-11-12
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 MED REL MEDTRONIC PUERTO RICO
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 Date2014-09-28
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC MED REL MEDTRONIC PUERTO RICO
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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