MAUDE Adverse Event Report: MEDTRONIC, INC. MEDTRONIC SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-20

Device Problems Fluid/Blood Leak (1250); Nonstandard Device (1420); Defective Component (2292)

Patient Problem Underdose (2542)

Event Date 08/12/2019

Event Type  Injury  

Event Description

My son's medtronic synchromed ii pump failed at the catheter.I don't believe it ever worked.For years it is probable that higher and higher.Doses of baclofen was spilling into his abdomen.Model #8637-20.Class i recall issued 2017? it took 5 years for a quick test to confirm our years long suspicions.The nurse practitioner at (b)(6) hosp claimed there were no recalls when i asked her today at the hosp with a dr present.This is serious because the pump people don't have a clue as to this pump's failure history.Fda safety report id# (b)(4).

• Brand Name: MEDTRONIC SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 8931238
• MDR Text Key: 155661296
• Report Number: MW5089308
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/01/2021
• Device Model Number: 8637-20
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 11 YR
• Patient Weight: 37