PERCEPT B35200

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-31 for PERCEPT B35200 manufactured by Medtronic Puerto Rico Operations Co..

Event Text Entries

[185961222] Percept ins is not approved in us at this time, but is similar to devices approved under mhy. (b)(4). If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[185961223] It was reported that the patient was experiencing electrical sensations around the ins site. After implant the impedance measurements were all normal, but one day later the sensations began and impedance was measured to be 40 ohms too high, slightly out of range. No true troubleshooting had been performed other than several impedance checks. The cause was not definitively determined, but it was stated there was "probably some fluid within the ins and extension. " a revision surgery to de- and reconnect the extension and ins was proposed, but the sensations had been becoming weaker. The patient decided to wait some days/weeks and if there was further improvement, no revision would be performed.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004209178-2020-06478
MDR Report Key9908227
Report SourceCOMPANY REPRESENTATIVE,FOREIG
Date Received2020-03-31
Date of Report2020-03-31
Date of Event2020-03-05
Date Mfgr Received2020-03-16
Device Manufacturer Date2019-12-02
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 NamePERCEPT
Generic NameSTIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR
Product CodeMHY
Date Received2020-03-31
Model NumberB35200
Catalog NumberB35200
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

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.