• 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 Problems Premature End-of-Life Indicator (1480); Battery Problem (2885)
Patient Problems Nausea (1970); Therapeutic Response, Decreased (2271); Sweating (2444); Shaking/Tremors (2515); Alteration In Body Temperature (2682)
Event Date 04/15/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a consumer regarding a patient receiving fentanyl (2000 mcg/ml at 900 mcg/day) via an implantable infusion pump. The indication for use was non-malignant pain. It was reported that the patient went to the emergency room because her pump was emitting a critical alarm and she was experiencing stomach problems, "was hot and cold at the same time", profusely sweating and feeling shaky. A device manufacturer representative came to the emergency room and tried to get the pump to start again but said that the pump had died early; the pump battery was expected to last until august. It was reported that the representative turned the pump alarm off and "lowered it to the lowest possible setting". The patient was prescribed fentanyl patches on her back to help with withdrawal by the managing healthcare provider (hcp). The patient was concerned because on (b)(6) 2017 she started hearing the critical alarm again, this was explained to the patient to be due to the reported low or depleted battery. The patients symptoms were reported as a sudden change. The caller was redirected to follow up with the hcp. No further complications have been reported as a result of this event.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received from a consumer indicated that the pump had been alarming every 10 minutes. It was reported that the healthcare provider (hcp) was gone for over a week and the caller requested to have a device manufacturer representative contacted to stop the patients pump alarm. No further complications have been reported as a result of this event.
 
Manufacturer Narrative
(b)(4). If information is provided in the future, a supplemental report will be issued.
 
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 Key7440398
MDR Text Key105884954
Report Number3004209178-2018-08312
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 consumer
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/14/2013
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/26/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/14/2011
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-