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

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).

• Brand Name: PROMETRA II PROGRAMMABLE PUMP
• Type of Device: IMPLANTABLE 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 Key: 10484747
• MDR Text Key: 205483971
• Report Number: 3010079947-2020-00284
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00810335020228
• UDI-Public: (01)00810335020228(10)21700(17)161110
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P080012
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• 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 Received: 09/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2016
• Device Model Number: 13827
• Device Catalogue Number: 13827
• Device Lot Number: 21700
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/12/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention