FDA.reportPublic FDA data

MAUDE MDR 9884511

MDR report key
9884511
Report number
3004209178-2020-06199
Event key
0
Event type
3
Date of event
2020-02-01
Date received
2020-03-26
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
LISA WOODWARD CLARK
Address
7000 CENTRAL AVENUE NE RCW215 MINNEAPOLIS MN 55432 US
Phone
763-763-7635
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SYNCHROMED IIPUMP, INFUSION, IMPLANTED, PROGRAMMABLEMEDTRONIC PUERTO RICO OPERATIONS CO.LKK8637-208637-20* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12020-03-260

Event Narratives#

N

Patient 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

INFORMATION WAS RECEIVED FROM A CONSUMER ON (B)(6) 2020 REGARDING A PATIENT RECEIVING UNKNOWN BACLOFEN (DOSE AND CONCENTRATION UNKNOWN) VIA AN IMPLANTED INFUSION PUMP. IT WAS REPORTED THAT THE PATIENT'S PUMP HAD BEEN EMPTY SINCE THE FIRST OR SECOND WEEK IN (B)(6) 2020. IT WAS NOTED THAT THE PATIENT COULD NOT GET ANYONE TO FILL THE PUMP. THE PATIENT'S INSURANCE CHANGED AND THE CURRENT HEALTHCARE PROVIDER (HCP) WOULD NOT FILL THE PUMP. THE PATIENT FOUND A NEW HCP THAT WAS WILLING TO SEE THE PATIENT, HOWEVER, THE NEW HCP WAS REQUIRING A REFERRAL FROM THE PREVIOUS HCP AND THE PATIENT'S FAMILY COULD NOT GET ANYONE FROM THE PREVIOUS HCP'S OFFICE TO CALL THEM BACK ABOUT A REFERRAL. NO PATIENT SYMPTOMS WERE REPORTED AND NO FURTHER COMPLICATIONS WERE REPORTED OR ANTICIPATED.