UNKNOWN IMPLANTABLE NEUROSTIMULATOR NEU_INS_STIMULATOR

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2019-04-12 for UNKNOWN IMPLANTABLE NEUROSTIMULATOR NEU_INS_STIMULATOR manufactured by Medtronic Neuromodulation.

Event Text Entries

[141953118] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[141953119] Information was received from a healthcare provider (hcp) via a manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins) for the treatment of dystonia. It was reported there was impedance issues after replacement. It was unknown if any environmental/external/patient factors contributed to the issue. It was unknown if any diagnostics or troubleshooting were done. No symptoms or complications were reported or anticipated.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3007566237-2019-00855
MDR Report Key8510688
Report SourceCOMPANY REPRESENTATIVE,HEALTH
Date Received2019-04-12
Date of Report2019-05-02
Date Mfgr Received2019-05-02
Device Manufacturer Date2018-05-30
Date Added to Maude2019-04-12
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 MN 007771200
Manufacturer CountryUS
Manufacturer Postal Code007771200
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameUNKNOWN IMPLANTABLE NEUROSTIMULATOR
Generic NameIMPLANTED SUBCORTICAL ELECTRICAL STIMULATOR (MOTOR DISORDERS)
Product CodeMRU
Date Received2019-04-12
Model NumberNEU_INS_STIMULATOR
Catalog NumberNEU_INS_STIMULATOR
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC NEUROMODULATION
Manufacturer Address800 53RD AVE NE MINNEAPOLIS MN 554211200 US 554211200


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-04-12

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