MAUDE Adverse Event Report: MEDTRONIC MINIMED MEDTRONIC INTRATHECAL BACLOFEN PUMP; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-40

Device Problems Break (1069); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Pain (1994); Cramp(s) /Muscle Spasm(s) (4521)

Event Date 08/26/2022

Event Type  Injury  

Event Description

I am a quadriplegic.My medtronic baclofen pump stopped working, which prevented me from getting the baclofen i need, which caused severe muscle tightness and severely intensified my chronic pain, and now requires me to get surgery to fix the problem.When this pump malfunctions, it essentially ruins my life until i can have it fixed.I deal with chronic pain regularly from my sci, but this malfunction pushes it to an intolerable level.Had this been the only problem i had with this pump, i would have thought it was bad luck, but now that it's happened again, i wonder if there could be some sort of defected device.I've had four pumps so far.The first pump i had for nine years, the second for five years, the third for 3.5 years, and now this fourth one for 15 months.These pumps are supposed to last six to seven years, but only one of the five pumps i've had has lasted that long, and it was the first one i got in (b)(6) 2004.The second i got in (b)(6) 2013, the third in (b)(6) 2018, and that was replaced on (b)(6) 2021 when the battery died.Now that last one is broken again with an unknown issue, and i'm forced to get another one.I am reporting this in case it is not bad luck, and is in fact a wide-spread issue that has been underreported.Fda safety report id# (b)(4).

• Brand Name: MEDTRONIC INTRATHECAL BACLOFEN PUMP
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 15338793
• MDR Text Key: 299154505
• Report Number: MW5111830
• 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: 08/29/2022
• 4 Devices were Involved in the Event: 1 2 3 4

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 8637-40
• Was Device Available for Evaluation?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: BACLOFEN
• Patient Outcome(s): Other; Hospitalization; Required Intervention; Disability
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White