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

Model Number 8637-40

Device Problem Failure To Service (1563)

Patient Problem Erosion (1750)

Event Date 04/24/2018

Event Type  malfunction  

Manufacturer Narrative

Product id: 8780, serial# (b)(4), implanted: (b)(6) 2017, product type: catheter.Other relevant device(s) are: product id: 8780, serial/lot #: (b)(4), ubd: (b)(6) 2019, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider regarding a patient receiving gablofen, dose and concentration not reported via an implantable pump.The indication for use was intractable spasticity.The healthcare provider reported the patient had missed a refill and when the healthcare provider contacted the patient¿s family they said the patient was hospitalized now with pneumonia and that was the reason the patient was not seen for the refill.The healthcare provider also stated that the patient¿s family also stated that the catheter was exposed thru the skin.The healthcare provider was unaware if the patient had any therapy issues.The healthcare provider was wondering how they should medically manage the exposed catheter before contacting the patient¿s pump managing healthcare provider.No further complications were reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received on 01-jun-2018 from a healthcare professional (hcp) who reported that they called a home health agency and had the patient¿s pump refilled at the nursing home on (b)(6) 2018.Nothing had been done as of yet with regards to the catheter erosion.They advised the medical staff at the hospital to make the physicians aware of the erosion.The devices were still implanted.The hcp was going to follow up to make sure that the patient was referred for surgery when medically stable.No further complications have been reported as a result of this event.

• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7517885
• MDR Text Key: 108376364
• Report Number: 3004209178-2018-11010
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530126
• UDI-Public: 00643169530126
• 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: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2018
• Date Device Manufactured: 11/20/2017
• 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 Age: 33 YR
• Patient Weight: 121