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

Model Number 8637-40

Device Problem Material Integrity Problem (2978)

Patient Problem Cerebrospinal Fluid Leakage (1772)

Event Date 04/04/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id: 8780, serial#: (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2022, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: 22-sep-2017, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) and a company representative regarding a patient receiving morphine via an implanted pump.The indication for pump use was non-malignant pain.It was reported that during a back surgery neurosurgery reported that the catheter was cut during micro discectomy.The patient status was reported as ¿alive ¿ with injury¿ with the details of the injury noted as ¿csf (cerebrospinal fluid) leak¿.The environmental, external, or patient factor that may have led or contributed to the issue was noted to be that the catheter was not visible on x-ray.A portion of the catheter was removed during the procedure, and it was noted that the catheter would have to be replaced at a later time.The pain physician was turning the pump down to minimum rate as the pump was no longer connected to a catheter.The issue was not resolved at the time of the report.

• 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: 14039899
• MDR Text Key: 288772582
• Report Number: 3004209178-2022-04357
• 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: 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2017
• 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: 04/04/2022
• Initial Date FDA Received: 04/07/2022
• Date Device Manufactured: 05/05/2016
• 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: 70 YR
• Patient Sex: Male