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

Model Number 8637-40

Device Problem Pumping Stopped (1503)

Patient Problems Abdominal Pain (1685); Itching Sensation (1943); Muscle Spasm(s) (1966); Pain (1994); Therapeutic Response, Decreased (2271)

Event Date 03/06/2017

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer and a manufacturer representative regarding a patient receiving unknown baclofen 3000.0mcg/ ml for a total dose of 1433.7mcg/day via an implantable pump for intractable spasticity and cerebral palsy.It was reported on (b)(6) 2017 consumer stated they took patient to refill pump at healthcare professional's (hcp) office.It was noted patient was originally due for a refill on (b)(6) 2017 with an appointment on (b)(6) 2017, but ended up there on (b)(6) 2017.Family member/friend stated that the patient was 3 hours away from this office.It was reported on 2017-mar-06 pump was alarming and going off every 10 minutes (meaning dual alarm) and hcp office said it may be something with the wiring.It was noted they were told to call manufacturer and request a manufacturer representative (rep) to come to the home and check the pump and see why it is alarming.It was noted that patient has not had any medical procedures or environmental exposures.It was noted sound was consistent with synchromed alarms.It was noted that patient had a recent pump refill on (b)(6) 2017.Patient was to follow up with hcp.Rep role was reviewed and directed them to determine next best steps in getting the pump alarm checked.It was noted that patient was working on locating another hcp that was closer, but had not found one yet.It was up to the patient on what will be best for the patient for the next steps.It was stated patient presented to the emergency room as the pump was alarming.It was reviewed that the pump will need to be interrogated to determine the cause of the alarm.It was noted that patient had symptoms of abdominal pain, but no itching or increased spasticity.It was later noted that a motor stall was seen at initial interrogation and patient did not recently have an magnetic resonance imaging (mri).Pump status and/or event log report showed motor stall occurred and was active.It was reviewed to consider silence audible alarms, consider pump replacement, and consider programming to minimum rate.It was noted that if the pump was replaced/explanted to return to manufacturer for analysis.Patient reported itching, and patient was getting oral baclofen.Rep stated they are planning to replace the pump today ((b)(6) 2017) and send it back for analysis.It was reviewed options for manual bolus if catheter could not be aspirated.It was noted that pump logs showed stopped pump may exceed tube set yesterday ((b)(6) 2017).A prescription was given for oral baclofen, 10mg and 3 times per day when patient was at the emergency room on monday ((b)(6) 2017).It was noted that this was not sufficient as the patient was itching and spasms got worse so patient went back to the emergency room and they gave him benadryl.Patient was advised on (b)(6) 2017 to go to hospital where hcp was going to replace the pump today ((b)(6) 2017).Managing hcp information was given as patient found hcp to manage going forward.It was noted that patient has cerebral palsy and also stated that per caregiver the patient was experiencing periods of sustained clonus and that was not the patient's norm.No further complications were reported/anticipated.There was additional information reported that was not relevant to this event and therefore was omitted; (b)(4) low reservoir alarm; er.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from manufacturer representative on 2017-mar-22 reported she was present for patient's pump replacement who took place on (b)(6) 2017.Healthcare professional changed the medicine to lioresal 2000mcg/ml and set it to minimum rate while patient continued to received oral baclofen during hospital stay.The pump was picked up by another rep and returned to manufacturer per protocol for analysis.No further complications were reported/anticipated.

Manufacturer Narrative

Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.

Event Description

Additional information was received from a healthcare provider via a company representative.The pump was noted as having died prematurely.The patient experienced a sudden loss of therapy.The pump and catheter were returned to the manufacturer.

Manufacturer Narrative

Analysis of the sc connector of the catheter revealed coring/tears/cuts in seal and met leak criteria.Analysis of the pump revealed pump motor and gear train anomalies related to corrosion and/or wear and/or lubrication, and stall due to shaft-bearing.(b)(4).Eval code result code and eval code conclusion code applies to both the pump and catheter.Recent fda coding changes offer limited options for medical device evaluation conclusion coding.Medtronic selected conclusion code for the pump because, although the device was operating within specifications, medtronic modified the specifications making this the closest code available with respect to this event.Medtronic also selected conclusion code for the catheter because, although the device meets design specification, medtronic made enhancements to the design making this the closest code available with respect to this event.

Manufacturer Narrative

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

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: 6425117
• MDR Text Key: 70623314
• Report Number: 3004209178-2017-06154
• 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,consum
• Reporter Occupation: Other
• 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: 03/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2013
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2011
• 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): Required Intervention
• Patient Age: 30 YR