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

Model Number 8637-20

Device Problems Infusion or Flow Problem (2964); Material Integrity Problem (2978)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/01/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id: 8709sc, serial#: (b)(4), product type: catheter.Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4), ubd: 26-nov-2010, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from an unknown source regarding a patient who was receiving compounded baclofen (2000 mcg/ml at 936mcg/day) via an implantable pump for unknown indications for use.It was reported that patient¿s catheter would not aspirate successfully.The healthcare provider (hcp) removed the catheter and while attempting to removed from the epidural space entirely, only a portion of the catheter came out and the very tip of the catheter was completely sheared from the rest of the catheter within the spine and was unable to be found within the epidural space.Factors that have led to the issue were unknown.What was visible from the old catheter was removed and a new catheter was inserted.The issue was resolved at time of this report.Patient status was alive no injury.

• 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: 14021531
• MDR Text Key: 288665810
• Report Number: 3004209178-2022-04312
• 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: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2023
• 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: 04/01/2022
• Date Device Manufactured: 08/13/2021
• 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 Sex: Female