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

Model Number 8637-40

Device Problems Fluid/Blood Leak (1250); Material Integrity Problem (2978); Excessive Heating (4030)

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

Event Date 04/12/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant products product id: 8782, serial#: (b)(4), implanted: (b)(6) 2020, explanted: (b)(6) 2022, product type: catheter.Other relevant device(s) are: product id: 8782, serial/lot #: (b)(4), ubd: 17-apr-2021, 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 via a company representative regarding a patient receiving hydromorphone 2mg/ml at 1.5mg/day and bupivacaine 10mg/ml at 1.5mg/day via an implantable pump.It was reported that the patient had imaging done which showed fluid in the patients pump pocket.There were no environmental, external or patient factors that may have led or contributed to the issue.The dates of the studies on the pump were unknown.The actions and interventions taken to resolve the issue was they opened the pump pocket and the surgeon said he believed there was a small tear in the pump catheter.He removed the pump tubing just past the collet on the catheter.They opened a new catheter and used the pump connection segment only.The length removed matched the length added so the catheter length remained the same.Per the reporter the surgeon said the pump felt hot when he explanted and he wanted to replace it as well.The issue was resolved at the time of the report and it was noted that the healthcare provider wo uld not have any further information regarding the event.

• 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: 14134424
• MDR Text Key: 289426178
• Report Number: 3004209178-2022-04847
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630512
• UDI-Public: 00643169630512
• 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: 04/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• 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: 04/12/2022
• Date Device Manufactured: 09/04/2020
• 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: 68 YR
• Patient Sex: Male