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); Difficult to Advance (2920); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/12/2021

Event Type  Injury  

Event Description

Information was received from multiple sources (healthcare provider (hcp), clinical study) regarding a patient who was receiving clonidine (unknown dose and concentration), compounded baclofen (unknown dose and concentration), dilaudid (hydromorphone) (unknown dose and concentration), and bupivacaine (unknown dose and concentration) via an implantable pump for unknown indications for use. It was reported on (b)(6) 2021 the patient presented to the operating room for a pump replacement secondary to normal end of battery life and an occlusion at the proximal segment of the catheter was observed. The implanting physician was unable to insert the spinal segment in the desired space. The pump segment was coiled in the pump pocket and the pump was programmed to minimal rate. The plan was to refer to a neurosurgeon. On (b)(6) 2021 the existing catheter was removed, and a new catheter was attempted to be implanted but the spinal segment could not be threaded up to the desired level. Therapy was suspended and the pump was programmed to minimal rate. The outcome was noted as ongoing. The device diagnosis was catheter occlusion. The etiology of the event indicated the relationship of the event to the device or therapy was related and indicated the relationship of the event to the implant procedure was not related. The event date was (b)(6) 2021.

Manufacturer Narrative

Concomitant medical products: product id: 8781, serial#: (b)(4), implanted: (b)(6) 2015, explanted: (b)(6) 2021, product type: catheter. Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 20-nov-2016, 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: 12950775
• MDR Text Key: 281837990
• Report Number: 3004209178-2021-18094
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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: Study,Health Professional

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/14/2016
• 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: 04/26/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 10/21/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 12/07/2021 Patient Sequence Number: 1