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

Model Number 8637-40

Device Problem Positioning Problem (3009)

Patient Problems Fatigue (1849); Vomiting (2144); Dysphasia (2195); Ambulation Difficulties (2544)

Event Date 04/30/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8780, serial#: (b)(4).Implanted: (b)(6) 2020, product type: catheter.Other relevant device(s) are: product id:(b)(4), serial/lot #: (b)(4), ubd: 08-nov-2021, udi#: (b)(4).

Event Description

Information was received from a consumer regarding a patient receiving lioresal (2000 mcg/ml at 1075.5 mcg/day) via an implanted pump.The indication for pump use was intractable spasticity.It was reported by the patients mother on (b)(6) 2021 that the patient had been having problems with the pump ever since it was implanted.The pump took away the patients ability to walk instead of helping her to walk.Per the reporter, she had also had an infection in her teeth since before the pump and now she had not really woken up or eaten anything for the last few days; she had not passed much besides a few urines; she had been vomiting; and she had been to the emergency room 3 times in the last 3 days.In (b)(6) 2020, she stopped talking and the ct scan that was done did not show anything.The patients mother was calling because she was wondering if oral antibiotics could cause the pump to over-infuse.Additional information was received on 28-may-2021 from the patients mother who reported that the patient was still having the same issues as previously reported.The patient had been to the er (emergency room) 5 times and hospitalized 10 times since implant and hadnt been able to sit up or use her legs for a year.She had also lost her speech.Per the patients mother, the patient had an appointment scheduled to have the catheter moved down as they felt the catheter was too high, but she believes the hcp (healthcare provider) was chickening out because the surgery had been moved.She was calling to ask where the catheter should be placed as it was currently at t5.Implant consideration were reviewed, and the patients mother was redirected to the patients hcp.She stated that another physician had initially implanted the pump and they may follow up with them.

• 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: 11964355
• MDR Text Key: 255078914
• Report Number: 3004209178-2021-09043
• 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
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2021
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2021
• Date Device Manufactured: 12/21/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 29 YR