• 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 Problem Unstable (1667)
Patient Problems Abdominal Pain (1685); Pain (1994)
Event Date 11/15/2017
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received from a patient who was receiving bupivacaine and morphine (unknown) at an unknown concentration and dose via intrathecal drug delivery pump for non-malignant pain. It was reported that the pump had become loose in the pocket and was causing pain. It was reported that when the patient saw his new refill healthcare provider (hcp) at the initial assessment she told him that the pump felt loose. Before the patient met with his new refill hcp he had a computed tomography (ct) scan and colonoscopy to help diagnose the reason for the pain. The reported symptoms were pain, mostly underneath the pump (located on the right side of the abdomen) and all around the pump and as the day progresses gets real bad abdominal pain. This was considered a gradual change in symptoms; the patient said not falls or trauma. It was reported "about 3 months ago" for pump breaking loose and pain, and the week before this report date, pain worse all around and bottom of the pump. It was reported that the pump itself was working fine. 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
lisa woodward clark
7000 central avenue ne rcw215
minneapolis, MN 55432
7635263920
MDR Report Key7052922
MDR Text Key93244078
Report Number3004209178-2017-24247
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 consumer
Reporter Occupation
Type of Report Initial
Report Date 11/22/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/22/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/14/2018
Device Model Number8637-40
Device Catalogue Number8637-40
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 Received11/21/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/14/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-