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

Model Number 8637-40

Device Problem Occlusion Within Device (1423)

Patient Problems Underdose (2542); No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8596sc, serial# (b)(4) implanted: (b)(6) 2016, product type: catheter.Product id: 8703w, lot# l71615, implanted: (b)(6) 2000, product type: catheter.Information references the main component of the system.Other relevant device(s) are: product id: 8596sc, serial/lot #: (b)(4), ubd: (b)(4) 2016, udi#: (b)(4); product id: 8703w, serial/lot #: (b)(4), ubd: (b)(6) 2016, 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 clonidine and morphine, both of an unknown concentration and dose via an implantable infusion pump for spinal pain.It was reported that a catheter event was confirmed.The patient had a catheter blockage in the (b)(6) of 2017.The catheter was occluded.The pump was put to min rate and filled with saline since then.The patient would likely have a revision soon per the hcp.No symptoms were mentioned in regards to the event in 2017 fall.No further complications were expected or anticipated.

Manufacturer Narrative

Product id 8596sc, serial# (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2019, product type: catheter.Product id 8703w, lot# l71615, implanted: (b)(6) 2000, explanted: (b)(6) 2019, product type: catheter.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received via a company representative.It was reported that a catheter event was confirmed.The company representative was about to enter a case where they are doing a dye study today and suspected that they would be doing a catheter revision based off the results of the dye study.The patient was already at a minimum rate because they suspected there was a catheter issue because the patient had not been getting medication.The company representative had no further details on the case and was calling to confirm what revision kits could be used with the model 8703w.No patient symptom was mentioned.The date of the event was unknown.The pump was currently administering clonidine with concentration 500 mcg/ml at a minimum rate and morphine with concentration 35 mg/ml at a minimum rate.

Manufacturer Narrative

Product id: 8596sc, serial# (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2019, product type: catheter; product id: 8703w, lot# l71615, implanted: (b)(6) 2000, explanted: (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 healthcare provider via a device manufacturer representative indicated that they were unable to get flow through the old catheter.The catheter was replaced and discarded by the hospital.

• 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: 7592150
• MDR Text Key: 110783351
• Report Number: 3004209178-2018-13208
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/26/2019

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: 09/14/2017
• 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: 06/08/2018
• Initial Date FDA Received: 06/12/2018
• Supplement Dates Manufacturer Received: 08/09/2019; 08/22/2019
• Supplement Dates FDA Received: 08/14/2019; 08/26/2019
• Date Device Manufactured: 03/22/2016
• 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