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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 Inadequate Pain Relief (2388)
Event Date 09/17/2020
Event Type  Injury  
Manufacturer Narrative
Per follow-up, representative stated that during the revision, the pump was sutured down on two suture loops by the physician. It is unknown if the implanting physician sutured down the implant during the initial surgery. Device remains implanted and will not be returned. A review of the device history record, which includes verification of all steps in the manufacturing of the pump, verification of all final testing performed by/on the pump, verification of sterilization, and packaging for subject pump was performed. The review did not identify any non-conformances, issues or capas associated with pump function. 'pump flipping or twisting' is noted as a risk associated with the pump per the instructions for use, although in this case, it was reported to be related to the patient's 'twiddler's syndrome' rather than any allegation of device issue. Internal complaint number: (b)(4).
 
Event Description
Patient tracking specialist and outreach services representative contacted technical solutions to report that a patient's pump was flipped and manipulated. Technical solutions contacted the local sales representative for further information. From the conversation with the representative, the following was reported: patient was experiencing pain. Patient also reported that the "pump flipped a lot" with manual manipulation as it seems patient was rotating and flipping the pump around from the outside. Cap study was performed and physician was unable to aspirate. Physician decided to perform a revision surgery. Pump remains implanted and was not replaced. During revision surgery, catheter appeared completely twisted. Upon further inspection, it was noted that the catheter was broken into two pieces. The physician believed that the patient has "twiddler syndrome" by the appearance of the catheter and by what the patient mentioned. Physician believes the reason catheter broke was due to patient's manual manipulation. Mdr (b)(4) was recorded to capture the allegation catheter breakage and revision.
 
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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 07828
Manufacturer Contact
james bennett
120 forbes blvd
suite 170
mansfield, MA 02048
9734269229
MDR Report Key10691009
MDR Text Key211725805
Report Number3010079947-2020-00319
Device Sequence Number1
Product Code LKK
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,Followup
Report Date 09/17/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/19/2019
Device Model Number13827
Device Catalogue Number13827
Device Lot Number25282
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 Received10/28/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/19/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/16/2020 Patient Sequence Number: 1
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