• 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 Problems Sedation (2368); Lethargy (2560)
Event Date 08/17/2020
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: neu_unknown_prog, serial#: unknown, product type: programmer, physician. Other relevant device(s) are: product id: neu_unknown_prog, serial/lot #: unknown. If information is provided in the future, a supplemental report will be issued.
 
Event Description
On 2020-sep-01, information was received from an healthcare professional (hcp), via a manufacturer representative (rep), regarding a patient receiving baclofen (500 mcg/ml, 70 mcg/day). It was reported a programming error occurred on (b)(6) 2020. The rep stated the patient's pump had 500 mcg/ml drug and on (b)(6) 2020 at 11:12am, the pump was refilled with a 750 mcg/ml drug. They did not update the drug concentration in the pump. It was reviewed that the patient was getting 135 mcg/day based on how the pump was currently programmed. The rep stated the patient was a "little bit sedated or lethargic". Troubleshooting steps resolved the issue.
 
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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key10489851
MDR Text Key205882740
Report Number3004209178-2020-15346
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,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/10/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/03/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/28/2021
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/04/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/11/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-