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

Model Number 8637-20

Device Problems Device Or Device Fragments Location Unknown (2590); Aspiration Issue (2883); Detachment of Device or Device Component (2907); Infusion or Flow Problem (2964); Material Integrity Problem (2978)

Patient Problem Therapeutic Response, Decreased (2271)

Event Date 04/20/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8711, lot# unknown, serial# unknown, implanted: (b)(6) 2012, explanted: (b)(6) 2018, product type: catheter.Other relevant device(s) are: product id: 8711, serial/lot #: unknown, ubd: unknown, udi#: (b)(4).(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a foreign healthcare professional (hcp) via daiichi regarding a patient who was receiving gabalon with an unknown concentration at 350 mcg/day via an implantable pump for spinal cord sarcoidosis.It was reported that on an unknown date the drug dosage was increased because recently weak effectiveness for spasticity was observed.On (b)(6) 2018, during the abdominal operation to replace the itb pump, the drug could not be aspirated from the catheter.It was reported that the variability of the pump was checked; there was no abnormality.It was reported that according to the reasons above, dr.Matsumoto considered that there was a high possibility of catheter anomaly and decided to replace the indura catheter with an ascenda catheter.While the indura catheter was being removed, the tip part of the catheter near the anchor was found to be fractured and the tip part was missing.As dr.Matsumoto considered that it would be difficult to find the tip part of the catheter, a new ascenda catheter was placed with remaining the tip part of the indura catheter inside the patient's body.It was reported that the classification of severity of the event was 6 (serious).It was reported that the event was recovered with a date of recovery of 20 18-05-14.The causality was reported as related to the catheter and not related to the drug, pump, programmer.It was reported that it was unknown if it was related to the surgical procedure.No further complications were reported and/or anticipated.Additional information was received.It was reported that the itb pump replacement was due to normal battery depletion.It was reported that the serial number of the pump and catheter were both unknown at this time.It was reported that it was undetermined if there were any contributing factors or likely causes that led to the catheter fracture or the weak effectiveness for spasticity.It was reported that the pump and catheter will not be returned for analysis as they were discarded.No further complications were reported and/or anticipated.

Manufacturer Narrative

Pt identifier: (b)(6) no longer applies to this event.Event date (b)(6) 2018 no longer applies to this event.Initial reporter information for (b)(6) no longer applies to this event.Due to imdrf harmonization, any previously submitted device, method, result, and conclusion codes no longer apply to this event.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received.It was reported that the classification of severity of the event was reported as 6 (serious) and additional information received reported that the classification of severity of the event is 3 (serious).It was reported that treatment for the adverse event was that there was drug therapy in that there was dose changes.It was previously reported that the date of outcome of the event was (b)(6) 2018, and new information reported that the date of outcome was (b)(6) 2018.It was reported that the patient experienced withdrawal symptoms.It was reported that the pump operability test was performed on (b)(6) 2018.The drug volume as previous refill 18.0ml, the actual residual volume was 4.0ml and the residual drug volume on the programmer was 3.9ml.It was reported that a catheter x-ray study was performed on (b)(6) 2018 and there were no abnormal findings.On (b)(6) 2018, the patient's spasticity of lower limbs was worsened.On (b)(6) 2018, the patient started to experience clonus of lower limbs.On (b)(6) 2018, 5:00pm, the dose of intrathecal baclofen (itb) was increased from 350mcg/day to 385mcg/day.On (b)(6) 2018, the improvement was insufficient.Lioresal internal administration was started.On (b)(6) 2018, the pump replacement procedure was requested in neurosurgery department.On (b)(6) 2018, 11:00am, the itb pump replacement procedure was started.The pump was explanted and the catheter was removed.When confirming the flow of cerebrospinal fluid, nothing was dripped.It was judged that the catheter had an anomaly.The patient was in the decubitus position and the wound of the previous procedure was opened.The fixture on the intrathecal side catheter was fractured.The spinal cord side catheter from the part which was fractured could not be confirmed.Lumbar puncture was performed at l1/2.The new catheter was inserted into th8.The abdominal side catheter was inserted, connected to the connector and fixed.The new pump was inserted under the skin of left lower quadrant, connected to the catheter and fixed.On (b)(6) 2018, 1:00pm, the dose of itb was decreased from 300mcg/day to 250mcg/day.The catheter was checked with computed tomography (ct).The physician considered whether the indura catheter was not rigid enough.The ascenda catheter was placed instead and used continuously, so decrease in the trouble of catheter was expected.No further complications were reported and/or anticipated.

• Brand Name: SYNCHROMED II
• 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: 7549759
• MDR Text Key: 109418971
• Report Number: 3007566237-2018-01597
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2018
• 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
• Patient Age: 66 YR
• Patient Weight: 60