• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MDT PUERTO RICO OPERATIONS CO SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
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
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.
 
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSYNCHROMED II
Type of DevicePUMP, 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 Key6425117
MDR Text Key100597844
Report Number3004209178-2017-06154
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,consum
Reporter Occupation
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 Received03/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/28/2013
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/28/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/10/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/04/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/22/2017 Patient Sequence Number: 1
-
-