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

Model Number 8637-40

Device Problems Fluid/Blood Leak (1250); Kinked (1339); Material Integrity Problem (2978)

Patient Problems Muscle Weakness (1967); Overdose (1988); Dysphasia (2195); Sedation (2368); Underdose (2542)

Event Date 04/03/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial# (b)(6), implanted: (b)(6) 2015, product type: catheter.Other applicable components are : product id: 8780, serial# (b)(4), (b)(6), (b)(4), implanted: (b)(6) 2015, product type: catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) regarding a patient who was receiving baclofen with concentration 2000 mcg/ml at a dose rate of 96 mcg/day via an implantable pump for intractable spasticity.It was reported that the patient had a spine fusion last week and during the fusion they saw that the catheter was kinked so they ended up replacing the catheter.As per the manufacture¿s device registry, the catheter remained implanted and a new catheter accessory (model 8785) was implanted on (b)(6) 2018.The date of the event was reported as being (b)(6) 2018.The date (b)(6) 2018 is considered an approximate date of event (month and year specified only).When they unkinked the catheter, the catheter was leaking.They started the patient at the dose he was at before and since then the patient had been a little sedated, had looseness in the legs, and slurred speech.The changed in therapy/symptoms was described as having been sudden.The hcp was inquiring on steps to change the drug concentration since patient was at the lowest dose.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

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

Event Description

Additional information was received via a healthcare provider (hcp).Regarding the patient having been a little sedated, had looseness in their legs, slurred speech, and their intrathecal baclofen dose was too high, it was noted that the increased flow through the new/repaired catheter was believed to be the cause of the symptoms.It was further noted that the kinked and leaking catheter may have been delivering less medicine to the patient.Regarding the cause of the catheter kink and leak, it was indicated that the catheter was coiled, and fascia was sewn over, which was ¿likely the cause¿.Actions taken to resolve the catheter kink and leaking included the neurosurgeon having spliced the catheter with a repair kit.The portion of the catheter that was leaking was cut and the connector was used to connect the remaining ends.Regarding the actions/interventions taken to resolve the patient having been a little sedated, having looseness in their legs, slurred speech, and intrathecal baclofen dose being too high, it was noted that the patient was re-admitted, and the baclofen dose was decreased until the symptoms resolved.The catheter kink, catheter leak, and symptoms were reported as having been resolved.Regarding the current status of the device, it was indicated as having been still implanted and functioning well.

Manufacturer Narrative

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

Event Description

Additional information was received on behalf of (b)(4).It was indicated that on (b)(6) 2018, a spontaneous report was received from a physician via the manufacturer regarding a male (age not reported) who was being treated with baclofen 2000 mcg/ml.It was further noted that on (b)(6) 2018, additional information was received from an advanced practice registered nurse (aprn) on behalf of the reporting physician.On (b)(6) 2018, it was learned that the patient's race is caucasian, and he was (b)(6) at the time of the events.Additional medical history included spasticity (indication for intrathecal baclofen therapy), pain, itching, constipation, and acne.Concomitant products included amoxicillin 500 mg oral capsule at 1 capsule twice daily, baclofen 10 mg oral tablet at 10 mg every 6 hours as needed for signs of withdrawal, benadryl (diphenhydramine) 25 mg oral tablet at 1 tablet every 6 hours as needed for itching, polyethylene glycol 3350 oral powder for reconstitution (dose illegible) daily, senna (sennasoides) 8.6 mg oral tablet at 1 tablet daily as needed for constipation, acetaminophen 325 mg oral table tablet at 1 tablet by mouth every 4 hours as needed for pain, benzoyl peroxide 2.5% topical gel at one application at bedtime as needed for acne, cholecalciferol 1000 iu oral tablet at 1 tablet daily, adult multivitamin at 1 tablet orally daily, fluoxetine 20mg/5ml oral solution at 1.1 ml daily, cetirizine 10 mg oral tablet at 1 tablet daily, and levetiracetam 500 mg oral tablet at 1 tablet twice daily.On an unspecified date, the patient was diagnosed with scoliosis.On (b)(6), x-rays were performed (results not provided).Regarding the x-ray performed on (b)(6) 2018 (prior to spinal fusion), scoliosis was noted.The patient was hospitalized / required prolonged hospitalization.From (b)(6), the patient was admitted to the hospital for spinal fusion surgery with an admitting diagnosis of scoliosis.Intraoperatively, the catheter was noted to be kinked and was straightened during the spinal fusion surgery.Afterwards, the intrathecal baclofen (itb) dose was too high; the patient postoperatively experienced.No additional information was provided.The patient¿s weight was provided.

• 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: 7441197
• MDR Text Key: 105843740
• Report Number: 3004209178-2018-08339
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2016
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2018
• Initial Date FDA Received: 04/18/2018
• Supplement Dates Manufacturer Received: 05/24/2018; 06/25/2018
• Supplement Dates FDA Received: 06/13/2018; 06/28/2018
• Date Device Manufactured: 12/06/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 15 YR
• Patient Weight: 37