• 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 Premature Elective Replacement Indicator (1483); Pumping Stopped (1503)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/31/2021
Event Type  Injury  
Manufacturer Narrative
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 distributor regarding a patient receiving gabalon 210 mcg/day via an implantable infusion pump with an indication for use of hypoxic encephalopathy. It was reported that at the time of the refill in (b)(6) 2020, the elective replacement indicator (eri) was 7 months. Therefore, the patient was hospitalized from (b)(6) 2021 to replace the pump, but when performing interrogation, the eri became (b)(6) 2021. It was noted that it was unconfirmed whether the alarm was sounding. A refill was performed and it was confirmed that there was no abnormality in the variability. On (b)(6) 2021 the distributor met the attending physician and the logs were checked. After the occurrence of eri, it was confirmed that motor stall occurred and motor stall recovery occurred were repeated 5 times from (b)(6) 2021 to (b)(6) 2021. The pump replacement that was originally scheduled in april was to be performed on (b)(6) 2021 to replace it as soon as possible. It was indicated that the causality of the event was related to the pump. No further patient 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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11507718
MDR Text Key244127064
Report Number3004209178-2021-04456
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Remedial Action Notification
Type of Report Initial,Followup,Followup
Report Date 05/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/28/2015
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/07/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/21/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/13/2014
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1579-2013

Patient Treatment Data
Date Received: 03/17/2021 Patient Sequence Number: 1
-
-