• 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); Improper or Incorrect Procedure or Method (2017)
Patient Problems Bradycardia (1751); Fatigue (1849); Nausea (1970); Vertigo (2134); Vomiting (2144); Malaise (2359)
Event Date 04/25/2018
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 health care provider (hcp) via a manufacturer representative regarding a patient who received clonidine (600. 0mcg/ml, 149. 96mcg/day) in an implantable pump for an unknown indication for use. The patient medical history and concomitant medications were unable to be obtained. Two hours following a refill on (b)(6) 2018 (approximately 16:30), the patient experienced vomiting, nausea, sleepiness (also reported as tired), vertigo, bradycardia, dry mouth, and did not feel well. The pump was emptied and 3. 4ml of drug was missing. The expected reservoir volume (erv) was 39. 9ml and the actual reservoir volume (arv) was 36. 5ml(confirmed via provided session report). The issue was considered to be due to a pocket fill. There were no known environmental/external/patient factors that may have led or contributed to the issue. The refill was considered normal and nothing was noticed (in agreement with telemetry). The provide telemetry report from the refill indicated the erv was 17. 3ml and the arv was 17. 5ml. The pump was programmed to minimum rate. The patient was kept for monitoring. On (b)(6) 2018, the patient had no issue through the night. The patient was discharged and programming was resumed to clonidine 150mcg/day (plus 3 x 19. 99mcg bolus). The issue was considered resolved. The status of the patient was stated to be alive and with no injury. No further complications were reported/anticipated.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information was received. It was reported that the pump was refilled on (b)(6) 2018 at 13h30m with 40 ml clonidine with patient activations of 20 mcg 3x/day. It was reported that 4 hours after leaving a hospital, the patient arrived at the emergency. It was reported that the patient experienced no hypertension. It was reported that the event resulted in in-patient or prolonged hospitalization and the intervention was reprogramming that occurred on (b)(6) 2018. The pump was reprogrammed to 3. 65 mcg/day. It was reported that the event was related to the device or therapy. The event was reported as resolved without sequelae (b)(6)2018. No further complications were reported and/or anticipated.
 
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 Key7496922
MDR Text Key107689672
Report Number3004209178-2018-10418
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Recall
Type of Report Initial,Followup
Report Date 11/16/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/28/2016
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 Received11/14/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured03/31/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberZ-1060-2011

Patient Treatment Data
Date Received: 05/08/2018 Patient Sequence Number: 1
-
-