• 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 Application Program Problem (2880); Communication or Transmission Problem (2896); Adverse Event Without Identified Device or Use Problem (2993); Protective Measures Problem (3015)
Patient Problems Swelling (2091); Therapeutic Response, Decreased (2271); Anxiety (2328); Complaint, Ill-Defined (2331)
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products: product id: a820, serial #: unknown, product type: software. If information is provided in the future, a supplemental report will be issued.
 
Event Description
Information was received via manufacturer representative (rep) from a patient who was receiving morphine, unknown concentration at unknown dose via intrathecal drug delivery pump for non malignant pain. It was reported that following alert message occurred: no pump found. The patient attempted to give themselves a bolus this morning at 4:00 am, and the communicator read that the device could not be found. Patient confirmed that she was charging her communicator at 4:00 am and was on the call today to troubleshoot. She had an (b)(6) on her lap and moved away from the (b)(6) but still no pump was found. Where her pump was placed, it was hard for her to give herself a bolus. There was a "big swollen lump over her pump". The reported symptoms were panicking, nervous, anxious and possible withdrawal. No further complications were reported additional information was received from a healthcare professional (hcp) via manufacturer representative (rep). It was reported that pump pocket was swollen unable to interrogate. Patient was admitted and currently trying to find out the outcome of her in ot stay. Further follow up was in progress. 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 Key8793653
MDR Text Key151132408
Report Number3004209178-2019-13589
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,consum
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 07/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/16/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/14/2020
Device Model Number8637-40
Device Catalogue Number8637-40
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/08/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/24/2019
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: 07/16/2019 Patient Sequence Number: 1
-
-