• 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 Failure To Service (1563); Insufficient Flow or Under Infusion (2182)
Patient Problems Nausea (1970); Pain (1994); Therapeutic Response, Decreased (2271); No Code Available (3191)
Event Date 06/27/2018
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 consumer regarding a patient receiving intrathecal fentanyl (concentration and dose unknown) via an implanted pump for spinal pain and degenerative disc disease. It was reported the patient was currently admitted for possible withdrawal symptoms and no troubleshooting was done prior to the call. The caller did not have access to a programmer for further troubleshooting. The patient was currently in the hospital and possibly having withdrawal symptoms. It was reported the alarm never went off and the patient was told she was not due for ¿shot until the 3rd. ¿ it was also reported the patient did not know she had withdrawal symptoms, but something occurred later that she must be out of mediation. The reporter stated never got an alarm. The patient was admitted to the hospital on (b)(6) 2018 after she took herself there. She had symptoms such as terrible back pain like withdrawal symptoms such as yawning and feeling nauseated. The healthcare provider (hcp) gave her pain medications to take. It was noted the patient was given the wrong date and the alarm never went off. No further complications were reported/anticipated or expected.
 
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 Key7654944
MDR Text Key112879684
Report Number3004209178-2018-14756
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
PMA/PMN Number
P860004
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Type of Report Initial
Report Date 07/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/28/2016
Device Model Number8637-20
Device Catalogue Number8637-20
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/28/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/02/2014
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: 07/02/2018 Patient Sequence Number: 1
-
-