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

Model Number 8637-40

Device Problems No Audible Alarm (1019); Device Displays Incorrect Message (2591); Application Program Problem (2880); Human-Device Interface Problem (2949)

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

Event Date 12/05/2017

Event Type  malfunction  

Manufacturer Narrative

Refers to the main device, other components include: product id: 8835, serial# (b)(4), product type: programmer, patient.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient who was receiving demerol and marcaine at unknown concentrations and dosages via an implantable pump for non-malignant pain and failed back surgery syndrome.On (b)(6) 2017, it was reported that the patient's personal therapy manager (ptm) was showing an error code of 8286, indicative of an empty reservoir.It was confirmed that the patient had not recently had a pump refill.The patient's ptm showed a refill date of (b)(6) 2017, but the patient was scheduled for a refill on (b)(6) 2017.The patient noted that they did not hear a pump alarm, however, their ptm is showing a bell alarm.No symptoms were reported.No further complications were reported.

Manufacturer Narrative

Updated to reflect the information received on (b)(6) 2017.Device codes (b)(4) added and (b)(4) removed to accurately reflect the information received on (b)(6) 2017.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the patient's healthcare provider (hcp) on (b)(6) 2017.It was reported that the patient's pump had 9 cc's in it.The cause of the patient's pump alarm not being heard was not determined.No actions/interventions that were taken to resolve the patient's empty pump were reported.No further complications were reported.

Manufacturer Narrative

Other components include: product id 8835, (b)(4), product type: programmer, patient, product id: 8835, (b)(4), product type: programmer, patient.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: 7105950
• MDR Text Key: 95080509
• Report Number: 3004209178-2017-25775
• 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,Followup,Followup
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/28/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/08/2017
• Date Device Manufactured: 01/02/2014
• 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 Age: 67 YR