MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION IMPLANTABLE INFUSION PUMP; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number NEU_UNKNOWN_PUMP

Device Problems Disconnection (1171); Kinked (1339); Migration or Expulsion of Device (1395); Unstable (1667); Device Operates Differently Than Expected (2913); Material Integrity Problem (2978)

Patient Problems Cerebrospinal Fluid Leakage (1772); Unspecified Infection (1930); Complaint, Ill-Defined (2331)

Event Date 03/30/2018

Event Type  Injury  

Manufacturer Narrative

Section d information references the main component of one of the systems involved in the reported events; other applicable components are: product id: 8731sc, lot# unknown, product type: catheter.Product id: 8709, lot# unknown, product type: catheter.Product id: 8711, lot# unknown, product type: catheter.Product id: 8781, lot# unknown, product type: catheter.Product id: neu_unknown_pump, lot# serial# unknown implanted: explanted: product type: pump.Product id: 8731sc lot# unknown, product type: catheter.Product id: 8596 lot# unknown, product type: catheter.Information references the main component of the system.Other relevant device(s) are: product id: 8731sc, serial/lot #: unknown, ubd:, udi#: ; product id: 8709, serial/lot #: unknown, ubd:, udi#: ; product id: 8711, serial/lot #: unknown, ubd:, udi#: ; product id: 8781, serial/lot #: unknown, ubd:, udi#: ; product id: neu_unknown_pump, serial/lot #: unknown, ubd:, udi#: ; product id: 8596, serial/lot #: unknown, ubd:, udi#: ; pucks-faes e, hitzenberger g, matzak h, et al.Eleven years¿ experience with intrathecal baclofen - complications, risk factors.Brain and behavior.2018:e00965.B3: please note that this date is based off of the date of publication of the article, as the event dates were not provided in the published literature.If information is provided in the future, a supplemental report will be issued.[(b)(4)lit.Pdf].

Event Description

Summary: treatment with intrathecal baclofen (itb) is commonly used in patients with severe spasticity.However, complications may occur after implantation of the itb-device, albeit mainly procedure-and device-related problems.The aim of the study was to assess surgical-as well as catheter-and pump-related complications and define their risk factors.Reported events: a patient with a pathology of spastic paralysis experienced a catheter dislocation of the distal segment 64 days after their last surgical procedure.X-ray imaging confirmed the dislocation.An exchange of the entire catheter was performed.No further complications were reported or anticipated.A patient with a pathology of traumatic brain injury experienced a catheter dislocation of the distal segment 914 days after their last surgical procedure.Ct imaging confirmed the dislocation.An exchange of the entire catheter was performed.No further complications were reported or anticipated.A patient with a pathology of traumatic spinal injury experienced catheter dislocation of the distal segment 32 days after their last surgical procedure.No imaging was performed.An exchange of the entire catheter was performed.No further complications were reported or anticipated.A patient with a pathology of traumatic spinal injury experienced catheter dislocation of the distal segment 28 days after their last surgical procedure.X-ray showed no signs.An exchange of the entire catheter was performed.No further complications were reported or anticipated.A patient with a pathology of traumatic spinal injury experienced catheter dislocation of the distal segment 657 days after their last surgical procedure.X-ray showed the catheter at l3.Ct scan and contrast agent showed no signs.An exchange of the distal segment was performed.No further complications were reported or anticipated.A patient with a pathology of traumatic brain injury experienced catheter dislocation of the distal segment 2058 days after their last surgical procedure.Ct scan and contrast agent showed no signs.An exchange of the entire system was performed.No further complications were reported or anticipated.A patient with a pathology of traumatic spinal injury experienced catheter dislocation of the distal segment 12 days after their last surgical procedure.No imaging was performed.An exchange of the entire catheter was performed.No further complications were reported or anticipated.A patient with a pathology of traumatic spinal injury experienced cerebrospinal fluid leakage 24 days after their last surgical procedure.No imaging was performed.Blood patching was performed.No further complications were reported or anticipated.A patient with a pathology of hypoxia experienced cerebrospinal fluid leakage 16 days after their last surgical procedure.No imaging was performed.Extracorporal compression (also reported as abdominal compression) was performed.No further complications were reported or anticipated.A patient with a pathology of traumatic spinal injury experienced cerebrospinal fluid leakage 2200 days after their last surgical procedure.X-ray and contrast agent showed no signs, while ct scan and contrast agent confirmed leakage.An exchange of the entire system was performed.No further complications were reported or anticipated.A patient with a pathology of subarachnoidal hemorrhage experienced cerebrospinal fluid leakage 2270 days after their last surgical procedure.X-ray showed no signs.An exchange of the pump and proximal segment was performed.No further complications were reported or anticipated.A patient with a pathology of traumatic brain injury experienced catheter kinking 19 days after their last surgical procedure (first implantation or revision surgery).X-ray and contrast agent imaging revealed no signs.Surgical exploration revealed no obvious reason for the dysfunction of the entire system.After, the device functioned normally again (thus catheter kinking suspected as most likely etiology).No revision was performed.No further complications were reported or anticipated.A patient with a pathology of spinal ischemia experienced an unknown catheter dysfunction 2471 days after their last surgical procedure.Fluoroscopy showed no signs.Surgical exploration revealed no obvious reason for the dysfunction of the entire system.It was reported there was functional worsening of a hemi spastic syndrome.An exchange of the entire system was performed.No further complications were reported or anticipated.A patient with a pathology of spinal paralysis experienced catheter break 1570 days after their last surgical procedure.Ct scan and contrast agent showed no intradural contrast.An exchange of the entire system was performed.No further complications were reported or anticipated.A patient with a pathology of spastic paralysis experienced catheter disconnection 2179 days after their last surgical procedure.X-ray confirmed the disconnection, and ct scan identified "loop." an exchange of the entire system was performed.No further complications were reported or anticipated.A patient with a pathology of hypoxia experienced cerebrospinal fluid leakage 1822 days after their last surgical procedure.No imaging was performed.An exchange of the entire system was performed.No further complications were reported or anticipated.A patient with a pathology of disc herniation experienced a catheter disconnection 737 days after their last surgical procedure.No imaging was performed.An exchange of the entire catheter was performed.No further complications were reported or anticipated.A patient with a pathology of intracerebral hemorrhage experienced catheter disconnection 2470 days after their last surgical procedure.X-ray confirmed disconnection.An exchange of the pump and proximal segment was performed.No further complications were reported or anticipated.A patient with a pathology of traumatic brain injury experienced catheter kinking 115 days after their last surgical procedure.X-ray and contrast agent showed no signs.An exchange of the distal segment was performed.No further complications were reported or anticipated.A patient with a pathology of subarachnoidal hemorrhage experience catheter dislocation of the distal segment 25 days after their last surgical procedure.Ct scan, contrast agent, and fluoroscopy confirmed dislocation.An exchange of the distal segment was performed.No further complications were reported or anticipated.A patient with a pathology of traumatic brain injury experienced catheter dislocation of the distal segment 838 days after their last surgical procedure.Fluoroscopy showed no signs.An exchange of the entire catheter was performed.No further complications were reported or anticipated.A patient with a pathology of traumatic spinal injury experienced catheter disconnection 1864 days after their last surgical procedure.X-ray and ct scan showed no signs.An exchange of the entire catheter was performed.No further complications were reported or anticipated.A patient with a pathology of multiple sclerosis experienced catheter kinking 364 days after their last surgical procedure.X-ray, ct scan, and contrast agent showed no signs.An exchange of the entire catheter was performed.No further complications were reported or anticipated.A patient with a pathology of spastic paralysis experienced unknown catheter dysfunction 1174 days after their last surgical procedure.Mri showed no signs.An exchange of the distal segment of the catheter was performed.No further complications were reported or anticipated.A patient with a pathology of multiple sclerosis experienced catheter disconnection of the proximal segment 33 days after their last surgical procedure.Ct scan showed no signs.An exchange of the proximal segment was performed.No further complications were reported or anticipated.A patient with a pathology of spastic paralysis experienced cerebrospinal fluid leakage 44 days after their last surgical procedure.Mri confirmed the leakage.Blood patching was performed.No further complications were reported or anticipated.A patient with a pathology of disc herniation experienced a pump site infection 884 days after their last surgical procedure.No imaging was performed.An exchange of the pump was performed.No further complications were reported or anticipated.A patient with a pathology of intracerebral hemorrhage experienced a pump site infection 168 days after their last surgical procedure.No imaging was performed.An explant of the pump was performed.No further complications were reported or anticipated.A patient with a pathology of cerebral palsy experienced pump site infection 26 days after their last surgical procedure.No imaging was performed.An exchange of the entire system was performed.No further complications were reported or anticipated.A patient with a pathology of hypoxia experienced pump site infection 368 days after their last surgical procedure.No imaging was performed.An exchange of the entire system was performed.No further complications were reported or anticipated.A patient with a pathology of hypoxia experienced pump site infection 23 days after their last surgical procedure.No imaging was performed.An exchange of the entire system was performed.No further complications were reported or anticipated.A patient with a pathology of traumatic spinal injury experienced pump hypermobility 1683 days after their last surgical procedure.No imaging was performed.Pump exchange was performed.No further complications were reported or anticipated.

• Brand Name: IMPLANTABLE INFUSION PUMP
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7639433
• MDR Text Key: 112414719
• Report Number: 3007566237-2018-01899
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_UNKNOWN_PUMP
• Device Catalogue Number: NEU_UNKNOWN_PUMP
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/12/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention