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

Model Number 8637-20

Device Problem Fluid/Blood Leak (1250)

Patient Problems Abdominal Pain (1685); Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Type  malfunction  

Manufacturer Narrative

Other relevant components include: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2016, product type: catheter.Patient codes: (b)(4) apply to both the pump and the catheter.Device code: (b)(4) applies to both the pump and the catheter.

Event Description

Information was received from a consumer regarding a patient receiving dilaudid (hydromorphone) 40mg/ml for a total dose of 3.5mg/day via an implantable pump for spinal pain.It was reported the patient said that medicine was leaking.It was stated patient was told by healthcare professional (hcp) that the pump was leaking.Patient had a pump refill on (b)(6) 2017.It was stated the patient was in the emergency room (er) on sunday (b)(6) 2017.The patient was experiencing pain near kidneys and bladder.It was noted that the patient was not feeling like the therapy was working.The patient was in pain.A computed tomography (ct) scan was done in the er and er told patient there was leakage at t9 and in the flank area.Patient requested to schedule an appointment with a manufacturer representative (rep) and stated healthcare professional (hcp) told them to call manufacturer and ask them to be at the appointment.Rep's role was reviewed and patient was redirected to hcp to request to schedule with a rep.It was noted patient got upset and disconnected the call.Event date was unknown.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• 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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6340779
• MDR Text Key: 67738157
• Report Number: 3004209178-2017-04114
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2017
• 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?: No
• Date Manufacturer Received: 02/15/2017
• Date Device Manufactured: 11/17/2016
• 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