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

Model Number 863720

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 04/26/2013

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8731; serial#: (b)(4); implanted: (b)(6) 2003; explanted: (b)(6) 2013; product type: catheter.Other relevant device(s) are: product id: 8731, serial/lot #: (b)(4), ubd: 26-sep-2005, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient who was receiving fentanyl (unknown concentration or dose) via an implantable pump for unknown indications for use.It was reported that back in 2013 the patient's catheter was replaced and so the patient knows what withdrawals feels like.

• Brand Name: SYNCHROMED II
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer (Section G): MDT PUERTO RICO OPERATIONS CO; rd 31 km 24 hm 4; juncos PR 00777
• Manufacturer Contact: glen belmer ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 6122713209
• MDR Report Key: 14247116
• MDR Text Key: 290569229
• Report Number: 3004209178-2022-05436
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2009
• Device Model Number: 863720
• Device Catalogue Number: 863720
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/26/2022
• Date Device Manufactured: 11/12/2007
• 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: 53 YR
• Patient Sex: Female