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

Model Number 8637-20

Device Problems Occlusion Within Device (1423); Unstable (1667); Material Integrity Problem (2978)

Patient Problem Pain (1994)

Event Date 12/14/2017

Event Type  Injury  

Manufacturer Narrative

The main component of the device system; the other relevant components include: product id: 8780, serial# (b)(4), implanted: (b)(6) 2016, 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 (hcp) via a clinical study regarding a patient receiving morphine 5.0mg/ml for a total dose of 0.9771mg/day via an implantable pump for non-malignant pain.It was reported on (b)(6) 2017 the patient reported pain has been getting worse/had increased pain.On (b)(6) 2017 fluoroscopy revealed an occluded catheter line.On (b)(6) 2018 medication was administered and the patient was prescribed hydromorphone.On (b)(6) 2018 surgical observation found the catheter to have a "phone cord" appearance and pump was freely mobile.On (b)(6) 2018 other surgical intervention was performed on the entire system where the catheter was revised and there was a pump pocket revision.On (b)(6) 2018 the patient reported improved pain control.The device diagnosis was catheter occlusion and the clinical diagnosis was increased pain.The outcome of the event resolved without sequelae on (b)(6) 2018.The event date was (b)(6) 2017.The etiology of the event indicated the relationship of the event to the device or therapy was related and indicated the relationship of the event to the implant procedure was not related.No further complications were reported/anticipated.

Manufacturer Narrative

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 cause of the catheter occlusion/occluded catheter line was not determined.It was noted the patient's baseline weight was (b)(6) lbs.The clinical diagnosis was updated to increased pain to left lateral mid and low back.It was noted the pump was freely mobile causing movement of the pump.

Manufacturer Narrative

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 cause of the pump freely mobile and the catheter appearance like a phone cord was not determined.

• 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7245769
• MDR Text Key: 99180289
• Report Number: 3004209178-2018-02206
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/23/2018

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: 05/14/2018
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2018
• Initial Date FDA Received: 02/06/2018
• Supplement Dates Manufacturer Received: 02/19/2018; 03/22/2018
• Supplement Dates FDA Received: 02/20/2018; 03/23/2018
• Date Device Manufactured: 11/21/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 108