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 Itching Sensation (1943); Discomfort (2330)

Event Date 01/14/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8784, serial#: (b)(4), implanted: (b)(6) 2019, explanted: (b)(6) 2022, product type: catheter.Product id: 8782, serial# :(b)(4), implanted: (b)(6) 2018.Other relevant device(s) are: product id: 8784, serial/lot #: (b)(4), ubd: 08-may-2021, udi#: (b)(4) ; product id: 8782, serial/lot #: (b)(4), ubd: 29-mar-2019, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer (con) via a manufacturer representative (rep) regarding a patient who was receiving unknown drug via an implantable pump for non-malignant pain.It was reported that the patient stated not getting relief as well as having issues with itchiness on left abdomen when giving bolus.The patient also stated that the 40 ml pump was too big and was uncomfortable.The patient was unaware of any factors that may have led or contributed to the issue.A full system replacement was done on (b)(6) 2022.The issue was resolved at the time of report.The patient's medical history was asked but unknown.The patient's status at the time of report 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: 14138604
• MDR Text Key: 289757189
• Report Number: 3004209178-2022-04898
• 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: Consumer,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/18/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2020
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/13/2022
• Initial Date FDA Received: 04/18/2022
• Date Device Manufactured: 06/12/2019
• 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: 64 YR
• Patient Sex: Female
• Patient Weight: 59 KG