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

Model Number 8637-20

Device Problem Infusion or Flow Problem (2964)

Patient Problems Pain (1994); Swelling/ Edema (4577)

Event Date 11/10/2021

Event Type  Injury  

Event Description

Information was received from a consumer and a healthcare provider (hcp) via a company representative regarding a patient receiving baclofen (2000 mcg/ml at 444 mcg/day) and bupivacaine (10 mg/ml at 2. 221 mg/day) via an implanted pump. It was reported that the patient had increased pain and localized swelling in the back near where his catheter was spliced after a back fusion in 2009. There were no environmental factors that contributed to the issue. A dye study was attempted, but the hcp was unable to aspirate so no dye was pushed. No interventions had yet been taken. Surgical intervention was planned, but not yet scheduled. The issue was not resolved at the time of the report, and it was indicated that the hcp had no further information to provide regarding the event.

Manufacturer Narrative

Concomitant products: product id: 8578, lot#: hg23ybl03, implanted: (b)(6) 2019, product type: catheter. Product id: 8709, serial#: (b)(4), implanted: (b)(6) 2005, product type: catheter. Other relevant device(s) are: product id: 8578, serial/lot #: (b)(4), ubd: 02-nov-2019, udi#: (b)(4); product id: 8709, serial/lot #: (b)(4), ubd: 17-oct-2007, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

• 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: 14166112
• Report Number: 3004209178-2022-05040
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630505
• UDI-Public: 00643169630505
• 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,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 06/28/2020
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Date Device Manufactured: 01/02/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: KG
• Patient Outcome(s): Required Intervention