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

Model Number 8637-40

Device Problems Filling Problem (1233); Difficult To Position (1467); Improper or Incorrect Procedure or Method (2017); Positioning Problem (3009); Protective Measures Problem (3015)

Patient Problems Muscle Spasm(s) (1966); Muscular Rigidity (1968); Therapeutic Response, Decreased (2271)

Event Date 06/25/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a healthcare professional (hcp) via a manufacturer representative regarding a patient who was receiving baclofen [2000 mcg/ml] at a dose of 778 mcg/day via an implantable pump for an unknown indication for use.It was reported on (b)(6) 2018 that the patient had a pump replacement on (b)(6) 2018 due to normal battery depletion.Beginning early in the morning after on (b)(6) 2018 the patient began experiencing severe intrathecal baclofen (itb) withdrawal symptoms with quite a bit of spasms that were more severe from the patient¿s baseline and the spasms were getting worse as the day wore on.The event logs were normal and there were no pump stalls.The catheter volume was 0.216 ml.The nurse reported that the itb was pre-made in the hospital so they were unsure what type of itb it was and were suspecting that maybe the drug concentration was not prepared properly.It was also reported that the manufacturer representative had some concerns around the filling of the pump and the ¿lock out¿ mechanism causing some issue with drug delivery.It was related that at the replacement the hcp was able to aspirate the water from the pump and received 37 ml of water.The hcp rinsed the pump with 3 ml of drug and aspirated only 1 ml instead of the 3 ml and had difficulty aspirating.The hcp then refilled the 40 ml pump and used about 17 ml of drug but was only able to get 15 ml in the reservoir.At this time the hcp did not aspirate and attempt the refill again.Post-surgery, the hcp performed a priming bolus.As actions/interventions taken the pump was completely emptied (including internal pump tubing as per special procedures) and the pump was replaced on (b)(6) 2018 to eliminate the possibility of the device malfunctioning and causing withdrawal symptoms.In addition, it was noted that the pocket size was increased to allow for more space for the catheter.At the time of the report the issue was resolved and the patient status was unknown.The pump would be returned.The patient medical history, gender, age, and weight were asked but would not be made available.

Manufacturer Narrative

Product id 8840 lot# (b)(4) implanted: explanted: product type programmer, physician product id 8870bbu01 lot# (b)(4) implanted: explanted: product type software section d information references the main component of the system.Other relevant device(s) are: product id: 8840, (b)(4), ubd: ,(b)(4); product id: 8870, (b)(4), (b)(4), (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a foreign hcp via a manufacturer representative on 2018-jun-26.It was detailed that they w ere faced with too much resistance preventing them to place more drug when they were only able to insert 15 ml at the surgery.An approved needle was used to perform the fill.The report of the pump was completely emptied including the pump tubing was done the day after replacement when they were trying to ¿restart¿ everything and start from the beginning again with respect to filling and priming.Diagnostic testing to the catheter was done as the physician observed that the pocket was tight and perhaps that was kinking the catheter, but the catheter was confirmed to be patent at the replacement.The patient had spent some time in the intensive care unit (icu) due to the extreme baclofen withdrawal.It was confirmed that the patient was receiving effective therapy prior to replacement and that the dose after the replacement was the same dose as prior to replacement.In addition, it was confirmed that the drug concentration was properly prepared, and a full system prime was performed.As of yesterday, the patient was stable and receiving therapy.No further complications were reported or anticipated.

Manufacturer Narrative

Analysis identified no anomalies.Due to additional information received, (b)(4).If information is provided in the future, a supplemental report will be issued.

• 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: 7650937
• MDR Text Key: 112743793
• Report Number: 3004209178-2018-14673
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2018
• 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): Hospitalization; Life Threatening; Required Intervention