• 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 Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/01/2018
Event Type  malfunction  
Manufacturer Narrative
Concomitant medical products: product id: 8711, lot# unknown, implanted: unknown, explanted: unknown, product type: catheter. Other relevant device(s) are: product id: 8711, serial/lot #: unknown, ubd: unknown, udi#: asku. (b)(6). If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a foreign healthcare professional (hcp) via a manufacturer representative regarding a patient who was receiving baclofen 1000 mcg/ml at 400. 3 mcg/ml and morphine 6. 2 mg/ml at 2. 4818 mg/day via an implantable pump for an unknown indication for use. It was reported that there were volume discrepancies between aspirated and calculated volumes. The discrepancy during last refill was around factor 2 (twice as much drug in the pump as calculated). There were no reported patient symptoms. It was reported that there were no external factors known. It was reported that they checked the logs which revealed no problems with the pump. It was reported that a catheter issues is supposed. It was reported that no interventions/actions were taken to resolve the issue. It was reported that the issue was not resolved at the time of the report. It was reported that no surgical intervention was taken or planned. The patient status at the time of the report was alive-no injury. No further complications were reported and/or anticipated.
 
Manufacturer Narrative
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)
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 Key7711064
MDR Text Key115089075
Report Number3004209178-2018-16412
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2015
Device Model Number8637-40
Device Catalogue Number8637-40
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 Received08/08/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured04/11/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-