• 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 8637-40
Device Problems Excess Flow or Over-Infusion (1311); Application Program Problem (2880)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/29/2018
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 8835, serial# unknown, product type: programmer patient. Other relevant device(s) are: product id: 8835, serial/lot #: unknown. 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 an unknown drug at an unknown concentration and dose via an implantable infusion pump. The indication for use was noted to be spinal pain. It was reported that the patient had an mri and afterwards he "was clicking through the info and the info is wrong. " he stated the lockout parameters read: 6x/day and 6x/24hr which was correct, but then it said 1x/10min when it should have said 1x/120min. He said he looked at the parameters last week so he knew the information had changed. He stated that following the mri he thought "it gave me more than what it's supposed to. " he confirmed he had no symptoms but he had been able to successfully give several boluses since the mri ended. The patient was redirected to have his health care professional (hcp) check the pump and logs. No further complications were reported.
 
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 Key8019148
MDR Text Key125700576
Report Number3004209178-2018-24198
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 Non-Healthcare Professional
Type of Report Initial
Report Date 10/30/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/28/2019
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/29/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/05/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-