• 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 Excess Flow or Over-Infusion (1311)
Patient Problems High Blood Pressure/ Hypertension (1908); Low Blood Pressure/ Hypotension (1914)
Event Date 08/24/2019
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 health care professional (hcp) regarding a patient receiving morphine (10 mg/ml at 0. 5 mg/day) via an implantable infusion pump. The indication for use was noted to be non-malignant pain. It was reported that the patient presented to the hospital on (b)(6) 2019 with hypertension, the day after implant. The hcp was concerned that "the patient gave too much medication into the pump. " the patient was currently at the hospital. Another hcp called into report that they wanted to have the patient's pump stopped to see if it helped with the patient's low blood pressure. Note this conflicts with the previous report of hypertension. Considerations were reviewed with the caller. No further complications were reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Additional information received from a healthcare professional (hcp) reported the patient has a concentration of 10mg/ml of morphine in the pump. The patient had access to the personal therapy manager (ptm) of 0. 3 mg/ml. There was no issue with the pump or the catheter. The 24 hour dose was 0. 5 mg/ml. It was noted that the patient has a baseline of low blood pressure. On (b)(6) 2019 the patient's systolic was 105. Actions/interventions included lowered pump dose and deactivated access to ptm on (b)(6) 2019. The patient was alert and oriented. It was noted the issue has been resolved. The patient came into office on (b)(6) 2019 with all resolved issues. The patient's weight was not applicable. No further complications were reported/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 Key8944675
MDR Text Key155959792
Report Number3004209178-2019-16568
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 health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/29/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/14/2020
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/12/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/24/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/29/2019 Patient Sequence Number: 1
-
-