ENTERRA 37800

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-02-21 for ENTERRA 37800 manufactured by Medtronic Puerto Rico Operations Co..

Event Text Entries

[183754447] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[183754448] Information was received from a healthcare professional (hcp) regarding a patient with an implantable neurostimulator (ins). It was reported that the patient was at 7. 5 ma and had one adjustment in (b)(6) 2019. The hcp was able to palpate the ins but could not interrogate the device after several attempts. They were using the correct device and software card. A manufacturer representative (rep) was paged to assist the hcp. No patient complications were reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5


[184373437] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[184373438] Additional information was received and the health care professional stated that the inability to palpate the ins was resolved and the cause was unknown. No further complications noted or anticipated
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004209178-2020-03880
MDR Report Key9742079
Report SourceHEALTH PROFESSIONAL
Date Received2020-02-21
Date of Report2020-03-10
Date of Event2020-02-14
Date Mfgr Received2020-03-10
Device Manufacturer Date2019-07-17
Date Added to Maude2020-02-21
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 NameENTERRA
Generic NameINTESTINAL STIMULATOR
Product CodeLNQ
Date Received2020-02-21
Model Number37800
Catalog Number37800
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
10 2020-02-21

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