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

Model Number 8637-20

Device Problem Mechanical Jam (2983)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/25/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare provider (hcp) regarding a patient who was receiving an dilaudid with concentration 5 mg/ml at a dose rate of 1.5015 mg/day via an implantable pump for non-malignant pain and chronic low back pain.It was reported that magnetic resonance imaging (mri) was recently performed and a motor stall was seen at initial interrogation.The mri was not performed due to a suspected problem with the patient¿s device or therapy.A motor stall recovery had not occurred.It was further indicated that the patient had an mri at noon today ((b)(6) 2018) and it was 4:30 pm when caller first interrogated pump post mri and the pump was still stalled.The hcp was hearing the audible pump alarm.It was noted that regarding the mri, the mr scanner was a closed vertical scanner.It was indicated that an mri doc was previously emailed to the hcp prior to the mri, so supposedly the hcp had followed those conditions.At the time of the report, the hcp was to obtain a new set of logs in another 20 minutes to hopefully confirm the stall recovery.A change in therapy/symptoms was indicated as not having been applicable.No patient symptoms were reported.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): 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: 7225162
• MDR Text Key: 98544935
• Report Number: 3004209178-2018-01564
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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
• Reporter Occupation: Health Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 01/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/28/2016
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2018
• Date Device Manufactured: 07/09/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-0497-2013
• Patient Sequence Number: 1
• Patient Age: 48 YR