• 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 Filling Problem (1233); Protective Measures Problem (3015)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/27/2019
Event Type  Injury  
Manufacturer Narrative
Analysis results were not available at the time of this report. A follow-up report will be sent when analysis is completed. If information is provided in the future, a supplemental report will be issued.
 
Event Description
On (b)(6) 2020, information was received from a manufacturer representative (rep) regarding a patient receiving bupivacaine (40 mg/m l, 20 mg/day) and clonidine (2,500 mcg/ml, 1,250 mcg/day) via an implantable pump for malignant pain. Information received reported the patient came in for a refill on (b)(6) 2019, and they were only able to fill the pump with 16-17 cc of drug before they met a lot of resistance. The patient was brought back in on (b)(6) 2020 to refill the pump and they could not empty the residual volume. The healthcare professional (hcp) then attempted to fill the pump with 10 cc of preservative-free normal saline (pfns), and could not. They reached out to the rep, who then conferenced with a pump tech. They instructed the hcp to hold back negative pressure for about three minutes. The hcp confirmed that he was able to see bubbles in the syringe. The hcp clamped, emptied the syringe, then attempted to hold negative pressure for two more minutes, then clamped again. The hcp then successfully filled the pump with pfns and was able to aspirate all of the pfns and residual drug. The hcp was then able to fill the pump to capacity. Additional information was reviewed with the rep. Additional information was received from a rep on 2020-jun-02 indicated he was sending the pump back for analysis. Additional information was received again on 2020-jun-04 that reported that there were no external/environmental/patient factors that may have caused or contributed to the event. The cause for the refill difficulties were not determined as the pump managing healthcare provider was very experienced and they did not believe it was use error. The pump was replaced as the pump was older and with the problems they have had with the pump it was determined that they pump had become unreliable. The pump was replaced friday (b)(6) 2020. Additional information was received from a healthcare provider (hcp) via a rep on the return paperwork for the pump indicated the last three refills seemed to have had one way valve close. The hcp was an experienced manager of pumps. It was noted he called during one of these incidents and followed their suggestions. On, a couple of these incidents they were unable to get 2-3 cc¿s into the pump. This was after fully aspirating the pump. 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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key10128167
MDR Text Key194500330
Report Number3004209178-2020-09856
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 company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 06/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/14/2016
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/05/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/15/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/20/2014
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: 06/08/2020 Patient Sequence Number: 1
-
-