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

MAUDE Adverse Event Report: MEDTRONIC 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
 

MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-20
Device Problems Failure To Service (1563); Device Displays Incorrect Message (2591)
Patient Problems Abdominal Pain (1685); Therapeutic Response, Decreased (2271); Irritability (2421)
Event Date 06/02/2017
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 who was receiving morphine at an unknown concentration and dose via an implantable pump for non-malignant pain and failed back surgery syndrome. It was reported that the alarm began due to low reservoir. The sound of the alarm was consistent with the pump alarms. The patient had a scheduled appointment to have the pump filled on (b)(6) 2017. The healthcare provider (hcp) cancelled the appointment because the patient told them she had a new pain hcp. The patient had seen the new hcp one time. The new hcp wanted to put the patient back on oral medications because he ¿did not believe in the pump¿. It was stated that the pump ran out of medications on an unknown date in (b)(6) 2017 (stated (b)(6) then stated (b)(6)). The patient had pain in the stomach starting on (b)(6) 2017. The consumer asked if the pain pump would heat up when the pump had no medications. It was stated that the patient was having pain in the stomach where the pump was. The consumer thought that the patient was going through withdrawal because the patient was crabby and really short tempered. The withdrawal started on (b)(6) 2017. It was considered a gradual change in therapy/symptoms. It was stated that the patient was like a zombie when she was on oral morphine sulfate prior to implant. The patient would just sit in her chair. There were no further complications reported or anticipated.
 
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 the hcp via a manufacturer representative reported the patient was coming back that day (b)(6) 2017 to program the pump to off state. The patient had no way to have their pump refilled because they moved, and there was no provider that accepted the patient¿s insurance in that area. The representative stated the patient moved from somewhere else. The doctor who was programming the pump to off stated did not normally manage pumps, and the patient basically ¿showed up at the doctor¿s door step¿. The representative stated patient would be treated medically after the pump was programmed off as no one took the patient¿s insurance in that area.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer (Section G)
MEDTRONIC PUERTO RICO OPERATIONS CO.
road 31, km. 24, hm 4
ceiba norte industrial park
juncos PR 00777
Manufacturer Contact
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key6636752
MDR Text Key102004963
Report Number3004209178-2017-12720
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
Report Date 06/26/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/13/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/28/2015
Device Model Number8637-20
Device Catalogue Number8637-20
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 Received06/22/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/30/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-