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

Model Number 8637-40

Device Problems Obstruction of Flow (2423); Infusion or Flow Problem (2964)

Patient Problem Pain (1994)

Event Type  Injury  

Event Description

Information was received from a healthcare provider via a company representative regarding a patient receiving dilaudid 1mg/ml at 0.05mg/day via an implantable pump.It was reported that the patient recently presented to physician¿s office on (b)(6) 2022 with reports of withdrawal symptoms and poorly controlled pain.A catheter access study was attempted in office, but unsuccessful at accessing port site.The patient subsequently underwent a flouroscopically guided catheter access study on (b)(6) 2022 which was found to be non-patent.The environmental, external or patient factors that may have led or contributed to the issue was indura catheter with history of previous catheter revision on (b)(6) 2020 [see manufacturer¿s report number 3004209178-2020-16835].The actions and interventions taken to resolve the issue was the patient was taken to the or (operating room) today and placed in a right lateral position.The physician first opened the pump pocket and dissected out the pump and existing proximal segment.Because the patient had an older indura catheter with history of previous catheter revision, the physician had already decided that the existing catheter would be abandoned and replaced with a new catheter.The pump was disconnected from the proximal pump segment and placed on the sterile table.The physician then proceeded to open up the lumbar spine incision.The physician dissected down to the catheter and anchor site of the existing catheter.He then cut the spinal segment and tied it off using 0-0 perma-silk ties.The tip of the existing catheter was then glued with dermabond.The physician assessed the abandoned catheter and noted no leaking of csf (cerebral spinal fluid).The physician then proceeded to implant a new catheter with the new catheter tip at the t8 level.The physician then proceeded to tunnel the new spinal segment to the existing pump pocket.The new pump segment was attached to the spinal segment and collet.The physician then reattached the pump and proceeded to aspirate csf from the catheter access port without resistance.The pump was then placed back in the existing pump pocket, at which time the physician again checked to ensure that there was flow of csf by aspirating from the catheter access port.The incisions were then irrigated and closed.To reduce symptoms of overdose/toxicity, the concentration of the medication was reduced from dilaudid 3 mg/ml to dilaudid 1 mg/ml.The patient¿s dosing was reduced from dilaudid 0.6 mg/day to dilaudid 0.05 mg/day.The issue was resolved at the time of the report and it was noted that the healthcare provider would not have any further information regarding the event.

Manufacturer Narrative

Concomitant medical products: product id 8709 lot# serial# (b)(4) implanted: (b)(6) 2001 explanted: product type catheter product id 8596sc lot# serial# (b)(4) implanted: (b)(6) 2020 explanted: product type catheter section d information references the main component of the system.Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), ubd: 01-oct-2003, udi#: (b)(4); product id: 8596sc, serial/lot #: (b)(4), ubd: 24-oct-2021, udi#: (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: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14629943
• MDR Text Key: 293529551
• Report Number: 3004209178-2022-07317
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2020
• 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: 06/02/2022
• Date Device Manufactured: 05/10/2019
• 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 Sex: Male
• Patient Weight: 93 KG