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

Model Number 8637-40

Device Problem Mechanical Jam (2983)

Patient Problem Pain (1994)

Event Date 05/25/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient who was currently receiving baclofen with concentration 3000.0 mcg/ml at a dose rate of (b)(4) ¿mg/day¿ and dilaudid with concentration 1.0 mg/ml at a dose rate of (b)(4) mg/day via an implantable pump for intractable spasticity and other spasticity.A friend/family member of the patient reported that the patient was in a lot of pain.Excruciating back pain was further noted.The pain was described as having been there for a while but had got worse within the last 3 to 4 days beginning on (b)(6) 2018.The date (b)(6) 2018 is considered an approximate date of event (specific month and year known only).The pain had gotten really bad on (b)(6) 2018 the patient had been hospitalized because of the excruciating pain on (b)(6) 2018 and was still currently in the hospital.It was noted that the hospital had given all kinds of pain medicine to the patient.Magnetic resonance imaging (mri) was performed on (b)(6) 2018, overnight.The reason for the mri was to diagnose the patient¿s back pain which was indicated as not having been related to the patient¿s device.The reporter did not think the patient¿s pain was related to the device.The reporter was calling to ask about checking the pump post mri.It was indicated that they did not know if the pump turned itself back on or not.The patient was not scheduled to see their healthcare provider (hcp) until the (b)(6).The option of having the hospital request a company representative come to check the pump if needed was being considered.The reporter was redirected to the patient¿s hcp.At the time of the report, it was noted that there was no record of any call(s) from the hospital to the manufacturer made before the mri.No further patient complications have been reported as a result of this event.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7562791
• MDR Text Key: 109880071
• Report Number: 3004209178-2018-12423
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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
• Report Date: 06/01/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2014
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/30/2018
• Initial Date FDA Received: 06/01/2018
• Date Device Manufactured: 06/28/2013
• 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): Hospitalization
• Patient Age: 43 YR