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

Model Number 8637-40

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Unspecified Infection (1930)

Event Date 12/07/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8711, serial#: (b)(4), implanted: (b)(6) 2007, explanted: (b)(6) 2020, product type: catheter.Product id: 8598a, serial#: (b)(4), implanted: (b)(6) 2018, explanted: (b)(6) 2020, product type: catheter.Product id: 8709, lot#: j0039909r, implanted: (b)(6) 2000, explanted: (b)(6) 2020, product type: catheter.Product id: 8711, serial/lot #: (b)(4), ubd: 27-feb-2009, udi#: (b)(4).Product id: 8598a, serial/lot #: (b)(4), ubd: 24-apr-2020, udi#: (b)(4).Product id: 8709, serial/lot #: (b)(4), ubd: 24-apr-2020, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) via a clinical study regarding a patient receiving an unknown drug (unknown dose and concentration) via an implantable pump.It was reported per the hcp, the patient had an abscess ad it was decided to remove the pump and catheter.It was unknown what factors may have led or contributed to the issue.No diagnostics/troubleshooting was performed.Actions/interventions included surgical interventions where the complete pump system was explanted due to infection on (b)(6) 2020.It was noted that all of the devices were sent to pathology and then will be discarded per hospital protocol.It was noted that the issue was resolved at time of report.The patient's status at time of report was asked but unknown.It was noted the patient's weight and medical history were asked and will not be made available.The event date was (b)(6) 2020.No further complications were reported/anticipated.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10977981
• MDR Text Key: 221449985
• Report Number: 3004209178-2020-21507
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/09/2020

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2021
• 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: 12/07/2020
• Initial Date FDA Received: 12/09/2020
• Date Device Manufactured: 03/11/2020
• 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: 65 YR