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

Model Number 8637-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fall (1848); Ambulation Difficulties (2544); Cognitive Changes (2551)

Event Type  Injury  

Event Description

Information was received from a consumer regarding a patient who was receiving dilaudid at an unknown dose and concentration via an implantable infusion pump for spinal pain.It was reported that the patient was scheduled to a have a magnetic resonance imaging session because they were experiencing the inability to walk.It was unknown if the procedure was due to a problem with the device or therapy.It was stated the inability to walk started prior to (b)(6) 2016.No additional information was provided.No further complications were anticipated/reported.Additional information was received from a consumer.It was reported that the patient fell and was in the hospital.It was stated the hospital wanted the pump turned off and the pain managed orally.The hospital thought the walking issues may be related to the intrathecal drug delivery.It was reported the patient had mental problems and was not aware of their surroundings.It was stated the pump was reduced 50% over a month.The patient had an improvement in cognitive ability after the pump was reduced, but they still were not 100%.It was stated the mental issues happened around the same time the patient fell.No further complications were anticipated/reported.

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): 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: 6616532
• MDR Text Key: 76818561
• Report Number: 3004209178-2017-11759
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00613994779229
• UDI-Public: 00613994779229
• Combination Product (y/n): N
• 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: 06/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2014
• 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: 05/12/2017
• Date Device Manufactured: 09/24/2012
• 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