MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION MEDTRONIC II PAIN PUMP ; PUMP, INFUSION, IMPLANTED PROGRAMABLE

Model Number 8637-20

Device Problems Nonstandard Device (1420); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Pain (1994)

Event Date 12/10/2019

Event Type  Injury  

Event Description

Pump tubing failed since day one after myelogram was done, having replaced (b)(6) 2020 2nd surgery.Model 8637-20 has an fda number 1 recall knowing that i was refused replacement of recalled pump when they "llp replace tubing".Have been in severe pain since first surgery was done (b)(6) 2019.To me it's a ticking time bomb.Fda safety report id# (b)(4).

• Brand Name: MEDTRONIC II PAIN PUMP
• Type of Device: PUMP, INFUSION, IMPLANTED PROGRAMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION
• MDR Report Key: 9818505
• MDR Text Key: 183343062
• Report Number: MW5093674
• 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: 03/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 8637-20
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other; Disability
• Patient Age: 69 YR
• Patient Weight: 73