• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. 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, INC. SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE Back to Search Results
Model Number 8637-40
Device Problems Mechanical Problem (1384); No Flow (2991)
Patient Problems Neck Stiffness (2434); Shaking/Tremors (2515); Missed Dose (2561)
Event Date 10/09/2018
Event Type  Injury  
Event Description
Patient presented to ed via ems transfer from another healthcare facility for evaluation of baclofen withdrawal. Quad, vent-dependent patient resides in group home. Per staff at group home, patient began to have severe spasticity and tremor-like movements around 0100. When patient's synchromed pump was interrogated by spasticity rn at this facility, pump found to have stalled around 1900 the previous day. Pump had last been filled and reprogrammed 21 days previously. Eri at that time was 7 months (estimated battery life). Patient was scheduled to have surgery for baclofen pump replacement in three weeks' time. Prior to motor stall, patient was receiving 1451. 6 mcg/day of baclofen intrathecal via baclofen pump. Patient was immediately admitted to icu, with withdrawal symptoms including lactic acidosis, managed overnight until the pump was replaced the next day. Medtronic was notified of pump failure and a representative was present at the pump replacement surgery. The pump was sent with the medtronic rep. For analysis on why the pump failed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSYNCHROMED II
Type of DevicePUMP, INFUSION, IMPLANTED, PROGRAMMABLE
Manufacturer (Section D)
MEDTRONIC, INC.
7000 central ave., ne
minneapolis MN 55432
MDR Report Key8178638
MDR Text Key130923577
Report Number8178638
Device Sequence Number1
Product Code LKK
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 11/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8637-40
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/11/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/13/2018
Device Age6 YR
Event Location Other
Date Report to Manufacturer12/19/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 12/19/2018 Patient Sequence Number: 1
-
-