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

Model Number 8637-20

Device Problems Contamination (1120); Fluid/Blood Leak (1250); Device Ingredient or Reagent Problem (2910); Material Integrity Problem (2978)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/10/2022

Event Type  Injury  

Event Description

Information was received from a healthcare provider (hcp) regarding a patient receiving intrathecal clonidine (concentration and dose unknown) and compounded baclofen 100 mcg/ml (dose unknown) via an implanted pump.It was reported the event occurred post-operative on (b)(6) 2022.It was further reported the patient had withdrawal issues.Environmental/external/patient factors that may have led or contributed to the issue included possible piece of scar tissue in the catheter or the catheter was nicked with bovie causing withdrawals.Diagnostics/troubleshooting performed included multiple 30% one time bolus and no resolution.Actions/interventions included pump was contaminated in the operating room (or) and replaced.Once pump pocket was opened there was bloody cerebrospinal fluid (csf) return.It was noted there was a possible nick in catheter and drug was leaking out subcutaneous.A new pump and new pump segment were placed.The issue was resolved at the time of this report and the patient¿s status was ¿alive- no injury¿.The patient¿s weight and medical history were asked and would not be made available.Additional information was received from a healthcare provider (hcp) via a company representative (rep) on (b)(6) 2022 indicated regarding the pump being contaminated in the or, it was reported the doctor grabbed a handle of something that was not draped and grabbed the pump after he pulled it out of the patient.The pump and pump segment were replaced on (b)(6) 2022.Regarding the date the catheter was nicked and the patient started having withdrawal, it was reported this occurred on (b)(6) 2022.The doctor did not want to send back the pump segment or pump and it was discarded/destroyed.

Manufacturer Narrative

Concomitant medical products: product id: 8784, serial#: (b)(4), implanted: (b)(6) 2015, product type: catheter.Product id: 8780, serial#: (b)(4), implanted: (b)(6) 2015, product type: catheter.The main component of the system.Other relevant device(s) are: product id: 8784, serial/lot #: (b)(4), ubd: 29-sep-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: 14048335
• MDR Text Key: 290289194
• Report Number: 3004209178-2022-04407
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00763000422608
• UDI-Public: 00763000422608
• 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: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2023
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2022
• Date Device Manufactured: 09/28/2021
• 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: 71 YR
• Patient Sex: Male