• 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 Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/27/2022
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from multiple sources (manufacturer representative, healthcare provider) regarding a patient who was receiv ing dilaudid (2 mg/ml at unknown dose) via an implantable pump for unknown indications for use. It was reported that the patient received an approximate 4-5 ml pocket fill during regular scheduled pump refill session. The managing physician was teaching their staff how to perform a pain pump refill procedure. The physician accessed the pain pump reservoir successfully. They withdrew the expected volume of 1. 4 ml of old drug. This matched the tablets expected amount after interrogation of the pump. The physician then had the physician's assistant as well as the registered nurse try and access the pump again before filling the pump with the new drug. They injected 5 ml and tried to draw it back out unsuccessfully. The physician tried it again and was able to possibly draw back 1 ml at the most. The physician verified that they were not in the pump and was able to access the pump again. They tried injecting 1 to 2 ml and were able to as well as draw those ml back out. They continued to inject 5 ml at a time with successful aspirations of the drug back out of the pump until all 15-16 ml were injected into the pump. It was suggested that they monitor the patient to make sure there was no signs of overdose. 1 hour after the pocket fill  the patient was doing fine and was sent home. 2 hours and 45 minutes after the pocket fill the patient was still doing fine. Upon finishing the pump fill the physician decided to place the pump at minimum rate for 48 hours and will reassess the patient on (b)(6) 2022. It was unknown if the issue was resolved at the time of report. The patient's weight was asked but unknown. The patient's medical history included chronic low back and leg pain. The patient's status at the time of report was alive - no injury.
 
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
glen belmer
7000 central avenue ne rcw215
minneapolis, MN 55432
6122713209
MDR Report Key14252711
MDR Text Key290455279
Report Number3004209178-2022-05487
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/03/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/29/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/19/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-