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

Model Number 8637-20

Device Problems Premature Elective Replacement Indicator (1483); Inappropriate or Unexpected Reset (2959)

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

Event Type  Injury  

Event Description

Information was received from a healthcare provider via a manufacturer representative on (b)(6) 2017 regarding a patient receiving unknown baclofen (dose and concentration unknown) via an implanted infusion pump.The indications for use included intractable spasticity and multiple sclerosis.It was reported that the patient was last seen on (b)(6) 2017 for a refill, and the time to elective replacement indicator (eri) was 8 months.The patient came to the clinic again on the day of report because the pump was alarming, and logs showed that eri had occurred.The caller was redirected to the healthcare provider.No patient symptoms were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer representative on 2017-aug-01.It was reported that the cause of the premature eri was not determined.The patient was reportedly admitted to the hospital and the pump was scheduled to be replaced on (b)(6) 2017.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer representative on 2017-aug-02.It was reported that the pump was replaced on (b)(6) 2017, and was still alarming even though the representative silenced the alarm.Pump logs show multiple low battery resets on (b)(6) 2017.The pump off code was requested to disable the pump.

Manufacturer Narrative

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

Event Description

Additional information was received from a healthcare provider on 2017-aug-15.It was reported that the pump was replaced with the patient suffering no ill effects, and the pump was returned to the manufacturer.

Manufacturer Narrative

Analysis of the pump on (b)(6) 2017 revealed high battery resistance.Analysis of the pump on (b)(6) 2017 also revealed a pump motor gear train anomaly regarding corrosion and/or wear and/or lubrication; stall was due to the shaft-bearing.As per the pump¿s log, the following drugs were being administered as of (b)(6) 2017: baclofen with concentration 1,500 mcg/ml, and bupivacaine with concentration 6.0 mg/ml.(b)(4) is regarding the analysis finding of high battery resistance.Recent fda coding changes offer limited options for medical device evaluation conclusion coding.Medtronic selected (b)(4) because, although the device meets design specification, medtronic made enhancements to the design making this the closest code available with respect to this event.The (b)(4) is regarding the analysis finding of pump motor gear train anomaly regarding corrosion and/or wear and/or lubrication; stall was due to the shaft-bearing.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: 6756463
• MDR Text Key: 81484361
• Report Number: 3004209178-2017-15954
• Device Sequence Number: 1
• Product Code: LKK
• 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: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2012
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2011
• 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 Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 70