ASCENDA 8784

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-02-22 for ASCENDA 8784 manufactured by Medtronic Puerto Rico Operations Co..

Event Text Entries

[137310472] If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10


[137310473] Information was received from a healthcare provider (hcp) via a manufacturer representative on (b)(6) 2019 regarding a patient receiving gablofen (500mcg/ml at 50mcg/day) via an implanted infusion pump. The indication for use was intractable spasticity. The patient's medical history included severe spasticity. It was reported that the attached collets on the catheter included in the kit detached from the connector when the surgeon was handling it. The surgeon was trying to connect the pump segment to the spinal segment at the spine incision and the collets fell off. The patient was not experiencing any issues because of this. No diagnostics or troubleshooting were performed and there were no environmental, external, or patient factors that may have led or contributed to the issue. A new kit was opened and the connector was replaced during the implant procedure with a new one. The issue was resolved at the time of report and the patient's status was alive - no injury.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004209178-2019-03806
MDR Report Key8362673
Date Received2019-02-22
Date of Report2019-05-02
Date of Event2019-02-19
Date Mfgr Received2019-05-01
Device Manufacturer Date2018-12-20
Date Added to Maude2019-02-22
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 Report0

Device Details

Brand NameASCENDA
Generic NameCATHETER, INFUSION
Product CodeJCY
Date Received2019-02-22
Returned To Mfg2019-03-07
Model Number8784
Catalog Number8784
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
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 2019-02-22

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