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

Model Number 8637-20

Device Problems Particulates (1451); Device Operates Differently Than Expected (2913)

Patient Problems Fall (1848); Muscle Weakness (1967); Pain (1994); Complaint, Ill-Defined (2331); Ambulation Difficulties (2544)

Event Date 07/01/2017

Event Type  malfunction  

Manufacturer Narrative

Refers to the main device.Other components include: product id 8731sc, serial# (b)(4), implanted: (b)(6) 2009, product type catheter.

Event Description

Information was received from a patient who was receiving 1500.0 mcg/ml of clonidine at 581.9 mcg/day and 20.0 mg/ml of dilaudid at 7.758 mg/day via an implantable pump for non-malignant pain.On (b)(6) 2017, it was reported that the patient had experienced falls and the patient's catheter was believed to be an issue.According to the patient, they had taken "some falls" approximately 2 months prior to the date of the report.The patient had "5 falls in a week", which left them unable to walk.The patient noted that they have a pre-existing condition of neuropathy which affects one of their legs.However, the falls were on the patient's "good leg".The patient's healthcare provider (hcp) is reportedly concerned that the catheter may be an issue and might be causing the patient to be unable to walk.According to the patient, the hcp informed them that it was not uncommon for dilaudid to crystallize at the catheter tip and cause problems.The hcp reportedly wanted to do an mri to rule-out potential catheter issues or the patient's pre-existing arthritic spurs.The patient is unable to lie down for the mri and an mri with sedation was requested.2 mris were ordered, one with contrast and one without, as a previously performed ct scan was unable to obtain the image needed for assessment.It was later reported that the patient had a pump replacement due to normal battery depletion, but that the catheter was not replaced.The patient confirmed that their hcp suspected crystallization of the dilaudid forming.An mri was being performed that was due "partially" to the pump.The patient later reported their drugs as "clonidine: concentration: 1500 mg/ml - dose : 82.5 mg/day and 8.51 mcg/ml, dilaudid: concentration 20.0 mg/ml - dose : 1.099 mg/day and "7.758 mcg/ml ".Additional information was received on (b)(6) 2017.The patient again reported that they could not walk and did not know if they could make it to their hcp after the "scan for the pump check".The patient was inquiring about adjustments prior to mri no further complications were reported the patient¿s medical history included a pre-existing condition of neuropathy, a pre-existing condition of arthritic spurs, 2 laminectomies and a spinal fusion occurring 40 years prior.These were reported as being unrelated to the pump.

Manufacturer Narrative

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

Event Description

Additional information was received from patient who reported that the pump was currently delivering clonidine (1500 mcg/ml at 270.5 mcg/day) and dilaudid (20.0 mg/ml at 3.602 mg/day).The patient was calling for mri compatibility guidelines as she was having problems with her back.She had neuropathy in both legs and weakness in her left leg.The doctor recommended an mri of the lower and thoracic part of her back under sedation.In a week¿s timeframe, she had fallen 5 times.She couldn¿t walk and was in a wheelchair.The patient had leg pain from the left side, lower back into hip area and down the left leg; the pain radiated down the left leg.The event date was unknown by the patient.No further complications have been reported as a result of this event.

• 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: 6918714
• MDR Text Key: 89497525
• Report Number: 3004209178-2017-20752
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2016
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2018
• Date Device Manufactured: 04/13/2015
• 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 Age: 74 YR