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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FLOWONIX MEDICAL, INC. PROMETRA II PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP

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FLOWONIX MEDICAL, INC. PROMETRA II PROGRAMMABLE PUMP IMPLANTABLE INFUSION PUMP Back to Search Results
Model Number 13827
Device Problem Unintended Movement (3026)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/21/2020
Event Type  Injury  
Manufacturer Narrative
Clinical specialist reported, "this sticking out could have been due to the fluid found after the doctor got in there and discovered the pin hole leak. " device remains implanted. Per instructions for use, pump migration is included under the 'possible risks associated with programmable implantable pump'. Internal complaint number: (b)(4).
 
Event Description
Clinical specialist (cs) reported a patient's pump was reanchored due to "it was sticking out more. " according to the cs, "during the procedure there was clear fluid consistent with csf in the pocket. When the catheter was inspected there was a pinhole defect seen with leak of clear fluid consistent with csf. " catheter was revised (captured in related mfr 3010079947-2020-00282).
 
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Brand NamePROMETRA II PROGRAMMABLE PUMP
Type of DeviceIMPLANTABLE INFUSION PUMP
Manufacturer (Section D)
FLOWONIX MEDICAL, INC.
500 international drive
suite 200
mount olive, nj
Manufacturer Contact
james bennett
500 international drive
suite 200
mount olive, nj 
4269229
MDR Report Key10484747
MDR Text Key205483971
Report Number3010079947-2020-00284
Device Sequence Number1
Product Code LKK
UDI-Device Identifier00810335020228
UDI-Public(01)00810335020228(10)21700(17)161110
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P080012
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 08/12/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/10/2016
Device Model Number13827
Device Catalogue Number13827
Device Lot Number21700
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/12/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/10/2016
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/02/2020 Patient Sequence Number: 1
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