MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS MEDTRONIC SYNCHRO II DRUG INFUSION SYSTEM; PUMP, INFUSION, IMPLANTABLE, PROGRAMMABLE

Model Number 8637-20

Device Problems Device Alarm System (1012); Fluid/Blood Leak (1250); Nonstandard Device (1420); Defective Component (2292)

Patient Problems Pain (1994); Lethargy (2560)

Event Date 01/15/2019

Event Type  Injury  

Event Description

I had a medtronic synchro 2 pain pump implanted (b)(6) of last year.The device began to malfunction and leak in the beginning of 2019.I became very ill with worsening pain and lethargy resulting in the pump having to be replaced, fun (b)(6) this year.This was the 8637-20 model that has already been recalled and was supposed to have been fixed.Multiple employees at my drs have told me that they are seeing several of these devices come back.Do not believe that they have been fixed as required.Can you please look into this for me.Medication measured and found to be missing almost half of the medication through leakage.In addition when the device was removed, it was completely empty and no alarm ever sounded to make me aware of that.Thank you.Fda safety report id# (b)(4).

• Brand Name: MEDTRONIC SYNCHRO II DRUG INFUSION SYSTEM
• Type of Device: PUMP, INFUSION, IMPLANTABLE, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
• MDR Report Key: 8974949
• MDR Text Key: 157328018
• Report Number: MW5089631
• 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: Patient
• Type of Report: Initial
• Report Date: 09/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8637-20
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 51 YR
• Patient Weight: 73