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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/23/2022

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 8781, serial#: (b)(4), implanted: (b)(6) 2016, product type: catheter. Other relevant device(s) are: product id: 8781, serial/lot #: (b)(4), ubd: 15-dec-2017, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from multiple sources (healthcare provider, clinical study) regarding a patient who was receiving morphine, bupivacaine, clonidine, and compounded baclofen via an implantable pump for unknown indications for use. It was reported that the patient was scheduled for a catheter access port (cap) dye study as per clinic protocol, as the patient was being scheduled for a pump replacement secondary to normal battery depletion.   during the cap dye study, only 0. 1 ml of csf could be aspirated. The clinical diagnosis was catheter occlusion. The catheter would be further examined during the pump replacement to determine if revision is necessary. It was indicated the event was related to the device or therapy. No actions were taken and the event was ongoing.

• 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: 14220371
• MDR Text Key: 290800985
• Report Number: 3004209178-2022-05326
• Device Sequence Number: 1
• Product Code: LKK
• 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
• Report Date: 04/27/2022

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 04/28/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 10/29/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial