MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SYNCHROMED II; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8637-40

Device Problems Migration or Expulsion of Device (1395); Difficult to Advance (2920); Positioning Problem (3009)

Patient Problems Muscle Weakness (1967); Muscular Rigidity (1968); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Sedation (2368)

Event Date 02/19/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2019, product type: catheter.Product id: 8780, serial#: (b)(4), implanted: (b)(6) 2019, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 10-dec-2020, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) regarding a patient receiving gablofen (500 mcg/ml at 624.46 mcg/day) via an implanted pump.The indication for pump use was intractable spasticity.On (b)(6) 2019 the hcp reported that about 3 weeks ago the patient had a sudden increase in spasticity.Today, they were going to give the patient a single bolus to assess the patient¿s response to the medication since he had been experiencing the increase in spasticity.They had done a spiral ct last week and the results were normal.Additional information was received on (b)(6) 2019 from a healthcare professional who reported that there was no device issue, patient/therapy issue, or procedural issue.Per the hcp, the patient was not at a therapeutic dose.The dose was increased, and the increased spasticity was improving.Additional information was received on (b)(6) 2019 from a healthcare professional via a company representative who reported that the patient was complicated, and he was not responding to the medication.The spiral ct and nuclear medicine pump-o-gram studies were wnl (within normal limits), but the patient was so rigid.All of the residual pump volumes had been right on and he had not gotten any benefit from adding on boluses just like his test dose.The pump logs were run and reviewed showing 2 motor stalls and recoveries due to mris and both were less than 1 hour.The first was on (b)(6) 2019 from 0945 to 1022 and the second one was on (b)(6) 2019 from 1303 to 1340.Per the hcp, the pump was placed in (b)(6) 2019 and the patient was flaccid post-op.He was discharged in (b)(6) 2019 and started having some return of ue (upper extremity) and le (lower extremity) spasticity.They had been titrating his dose up gradually and even added in periodic boluses to get better upper extremity effect.The catheter tip was at t3 due to the patient¿s prior history of scoliosis and harrington rod placement which prevented the surgeon from getting it any higher.The patient had one day of flaccidity on (b)(6) 2019 that lasted about 6 hours and then his rigidity returned to the state that he had been in constantly now.His current daily dose was 899.27 mcg/day with a basal rate of 25.69 mcg/hour with a 75 mg bolus over 10 minutes every 6 hours and per this reporter the concentration of the baclofen was 2000 mcg/ml.Additional information was also received on (b)(6) 2019 from a different hcp who reported that the patient and his family wanted the hcps to be aggressive in determining what the root cause of the patient¿s therapy issue was.The pump follow-up doctor thought that because there were no reservoir volume discrepancies and the nuclear medicine study was normal that the issue would not be catheter related.Per this hcp, the patient¿s surgeon was very well versed/experienced and that maybe they could do an exploratory surgery with a possible catheter revision.This reporting hcp was going to consult with the other hcps and recommend that the radiologist compare the catheter tip placement from the implant procedure to today.Additional information was received on (b)(6) 2019 from a healthcare professional who reported that they were using commercially prepared medication in the pump.The pump was filled with gablofen initially and then they did switch him over to baclofen with no change in symptoms.They had done at least 3 to 4 refills at this point and all expected and actual residual volumes had been without discrepancy.The reason for the itb (intrathecal baclofen) therapy was spasticity which resulted from an incomplete tetraplegia from a motor vehicle accident (mva).They had done both the side port access with intrathecal safe dye and a nuclear medicine study and both read as normal.They had kept him at the 500 mcg/ml concentration to address the volume issue and he had been getting 75 mcg boluses plus the continuous basal rate.They felt they had tried everything.Additional information was received on (b)(6) 2019 from a healthcare professional who reported that the cause for the patient¿s lack of consistent effect had not been determined.The side port with spiral ct and the nuclear medicine pump-o-gram were both wnl (within normal limits) and medication was saved for a side port bolus like an itb (intrathecal baclofen) test dose on (b)(6) 2019.Additional information was received on (b)(6) 2019 from a healthcare professional via a company representative who reported that after implant, the therapy didn't seem to be helping.The patient never really got good efficacy from the pump since implant.Two dye studies were performed and showed that the drug was going intrathecal.They decided to replace the spinal end of the catheter today ((b)(6) 2019).Previously the catheter was placed at t3 and today they lowered it to t10 when they replaced the spinal segment.They removed 43.5 cm from the old catheter for the revision.The surgeon hypothesized/was concerned that the catheter may not have been intrathecal, so they replaced the spinal end today even though the dye studies showed no issues.After the revision, they primed the new intrathecal end only with 0.065 ml over 5 minutes.It was noted that the pump had previously been delivering gablofen (500 mcg/ml at 537.25 mcg/day) and was currently delivering gablofen (500 mcg/ml at 149.79 mcg/day).No further complications were reported/anticipated.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from an hcp via a manufacturer representative on 2019-nov-07.It was reported that on (b)(6) 2019 the patient presented to the emergency room (er) with symptoms of baclofen withdrawal.A ct scan showed subdural catheter migration.The environmental, external, or patient factors that may have led or contributed to the issue were unknown.The issue was not resolved at the time of report and it was unknown if surgical intervention was planned.The patient's status at the time of report was alive - no injury.Additional information was received from an hcp on 2019-nov-08.It was reported that the pump was working fine but they were still having a delivery issue with the catheter.There was not a clinical emergency, but the patient had been through two catheter revisions without evidence of clinical response.It was noted that "unusual diffusion issues looked like all the medication was going straight to his brain." the higher the dose, the more sedated the patient became.The ct finding and other tests were associated with a subdural catheter migration and the hcp wanted to consult with another physician before revising the catheter for the third time.It was noted that the patient had been treated for months and had not had any response.It was noted that the patient did have scoliosis from when they were young and had a pretty twisted spine, but the hcp did not know if this had any influence in the cerebrospinal fluid (csf) diffusion.At the time of report the patient's dose was around 1300mcg/day at a concentration of 500mcg/ml.The hcp noted that they were very experienced and so was the neurosurgeon, but they hadn't been able to correct the patient's issue.

Manufacturer Narrative

Product id: 8780, serial# (b)(4), implanted: (b)(6) 2019, product type: catheter; product id: 8780, serial# (b)(4), implanted: (b)(6) 2019, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from the rep on 2019-aug-28.The doctor did not think there was anything wrong with the catheter, and was able to easily draw back csf.He only revised at the request of the managing physician.The managing physician requested that the catheter be lowered from t2 to t10.In addition, the managing physician believes that the catheter tip was ventral and that¿s why it wasn't having as good and efficacy as they had hoped.Because of this, the catheter remnant is not being sent in for analysis.No further complications were reported/anticipated.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 8939254
• MDR Text Key: 160579340
• Report Number: 3004209178-2019-16487
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2020
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2019
• Date Device Manufactured: 12/27/2018
• 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: 56 YR