MAUDE Adverse Event Report: INTRATHECAL PAIN PUMP; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Device Problems Defective Device (2588); Patient-Device Incompatibility (2682)

Patient Problems Failure of Implant (1924); Pain (1994)

Event Type  Injury  

Event Description

I had a spinal cord stimulator implant and that malfunctioned then they implanted a pain pump, intrathecal catheter that was ultimately removed as well.Cause more issues than helped.I have pain in my back bc of these surgeries, it's been a nightmare.Reference report mw5116240.

• Brand Name: INTRATHECAL PAIN PUMP
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• MDR Report Key: 16673466
• MDR Text Key: 312640373
• Report Number: MW5116241
• 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: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Treatment: BENTYL; EFFEXOR; ESTROGEN PATCHES; FRUIT AND VEGGIE SUPPLEMENT CAPSULES ; HAIR SKIN AND NAILS GUMMIES; HYDROXIZINE; KLONOPIN; PROGESTERONE; PROTONIX
• Patient Outcome(s): Disability; Hospitalization; Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White