MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-20

Device Problem Occlusion Within Device (1423)

Patient Problems Pain (1994); Complaint, Ill-Defined (2331)

Event Date 10/31/2017

Event Type  Injury  

Manufacturer Narrative

The main component of the system and other applicable components are: product id: 8709, serial# (b)(4), implanted: (b)(6) 2008, explanted: (b)(6) 2018, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider via a clinical study regarding a patient receiving unknown drug via an implanted pump.The indication for use was non-malignant pain.It was reported the patient's catheter was explanted and replaced, on (b)(6) 2018, related to an adverse event.It was noted the catheter replacement was due to a catheter occlusion.The issue was noted as ongoing as of (b)(6) 2018.

Manufacturer Narrative

Concomitant medical products: product id: 8709, serial#: (b)(4), implanted: (b)(6) 2008, explanted: (b)(6) 2018, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from healthcare provider (hcp) via a clinical study indicated the cause of the catheter occlusion was not determined.No further complications were reported/anticipated.

Manufacturer Narrative

Additional review determined that the previously reported information pertaining to manufacturer's report # 3004209178-2018-05229 [catheter occlusion; increased pain] was previously reported.Additional information regarding this event will now be reported under this manufacturing number [increased pain, catheter occlusion].If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider via a clinical study on 2018-mar-09 regarding a patient receiving unknown medication (dose and concentration unknown) via an implanted infusion pump.The indication for use was non-malignant pain.It was reported that a catheter occlusion occurred on an unspecified date.It was noted that the event was ongoing.No patient symptoms were reported and no further complications were reported or anticipated.Additional information was received from a healthcare provider via a clinical study on 2018-mar-16.It was reported that the event occurred on (b)(6)2017.The pump was used to deliver dilaudid and bupivacaine.On (b)(6)2017, the patient reported a significant increase in back pain since undergoing magnetic resonance imaging (mri) on (b)(6)2017.The programming date from the most recent refill prior to the event was (b)(6)2017 at 09:10.Fluoroscopy was performed on (b)(6)2018 and showed the occluded catheter.Interventions included replacing the catheter on (b)(6)2018.The etiology indicated the event was related to the device/therapy and not related to the implant procedure.Additional information was received from a healthcare provider via a clinical study on 2018-mar-23.It was reported that the catheter occlusion was first reported to have occurred on (b)(6)2017.The catheter was replaced on (b)(6)2018 and the cause of the occlusion was not determined.Additional information received from healthcare provider (hcp) via a clinical study indicated the cause of the catheter occlusion was not determined.No further complications were reported/anticipated.

Manufacturer Narrative

Concomitant medical products: product id :8596sc, serial#: (b)(4), product type: catheter.Product id: 8709, serial#: (b)(4), implanted: (b)(6) 2008, explanted: (b)(6) 2018, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from a healthcare provider via a clinical study reported the issue resolved without sequelae on (b)(6) 2018.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 7367136
• MDR Text Key: 103395558
• Report Number: 3004209178-2018-05650
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• Combination Product (y/n): N
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2016
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/07/2018
• Initial Date FDA Received: 03/23/2018
• Supplement Dates Manufacturer Received: 04/25/2018; 05/16/2018; 11/29/2018
• Supplement Dates FDA Received: 04/27/2018; 05/17/2018; 11/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 78