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); Premature Elective Replacement Indicator (1483)

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

Event Date 09/05/2018

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 8840, serial# unknown, product type: programmer, physician.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (nurse) regarding a patient who was receiving gablofen with concentration 2000 mcg/ml at a dose rate of 800.7 mcg/day via an implantable pump for intractable spasticity.It was reported the patient¿s last pump refill was on (b)(6) 2018, and at that time the pump had 23 months until elective replacement indicator (eri) was to occur.It was further reported that eri had, however, unexpectedly occurred.The nurse was with the patient for about an hour and didn¿t hear an alarm.The patient was described as being quadriplegic and they didn¿t mention anything about hearing an alarm either.The alarm was not heard but was confirmed by telemetry.It was noted that eri occurred on (b)(6) 2018, and end of service (eos) was to occur on (b)(6) 2018.It was reported that the nurse had previously replaced their older model clinician programmer in the past and now had the new one, so they were not sure if it had something to do with that.It was indicated that the session data report looks a little different than what they were used to seeing.A telemetry strip acquired via the older model clinician programmer was provided.It was reviewed at the time of the report that there did not seem to be any anomalies with the report itself.No patient symptom was reported.Having the pump returned to the manufacturer for analysis if/when they replace the pump was being considered.The reporter was redirected to follow-up with the patient¿s healthcare provider to review considerations.On (b)(6) 2018, a company representative further reported that the patient was at end-stage m.S.(multiple sclerosis) and the healthcare provider was wondering what could have contributed to abnormal eri occurring.It was reviewed that the pump was not part of the battery performance communication sent out previously in (b)(6) 2017.It was being considered that they would not know the definite reason until the pump is returned for analysis.Covering the patient for potential withdrawal symptoms was being considered, since they did not know when eos would occur.Titrating down if considering discontinuation of intrathecal therapy was also being considered.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: 7969132
• MDR Text Key: 124138012
• Report Number: 3004209178-2018-23105
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2015
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/11/2018
• Initial Date FDA Received: 10/16/2018
• Date Device Manufactured: 09/10/2013
• 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 Age: 71 YR