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

Model Number 8637-40

Device Problems Filling Problem (1233); Migration or Expulsion of Device (1395); Obstruction of Flow (2423); Infusion or Flow Problem (2964); Material Integrity Problem (2978)

Patient Problems Seroma (2069); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/25/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant products: product id: 8709sc, serial#: (b)(4), implanted:(b)(6) 2013, product type: catheter.Product id: 8709sc, serial#: (b)(4), implanted: (b)(6) 2012, product type: catheter.Other relevant device(s) are: product id: 8709sc, serial/lot #: (b)(4), ubd: 09-feb-2014, udi#: (b)(4); product id: 8709sc, serial/lot #: (b)(4), ubd: 25-sep-2014, 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 (hcp) via a company representative regarding a patient receiving lioresal (2000 mcg/ml) via an implanted pump.It was reported that the patient went through withdrawal symptoms which raised concerns that there was something wrong with the pump and the nurse also could not get access for refill which raised concern for a pump flip.The patient was taken to surgery.A catheter revision was attempted but upon opening the pocket, the physician found yellow fluid in the pocket and wanted to send it for labs before progressing with putting a new catheter in.The catheter was checked through the cap (catheter access port) and two other connections, but the catheter didn¿t seem to aspirate back.The catheter was twisted and kinked multiple times.During the procedure, they relieved all the kinks and cut the old catheter and there was still no backflow of csf (cerebrospinal fluid) and it was negative for aspiration.A new pump connector was implanted to hook back up to the pump.The pump logs were checked, and the logs were good.The pump was filled with 40 cc and no prime was done due to the negative aspiration.The new starting dose was started at 150 mcg/day because they had tried to fix the catheter during the procedure.They were going to wait until the labs came back to either go back in and fix the catheter or explant if infected.The issue was not resolved at the time of the report.

• 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: 13964130
• MDR Text Key: 288275206
• Report Number: 3004209178-2022-04046
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/31/2022

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/14/2020
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2022
• Initial Date FDA Received: 03/31/2022
• Date Device Manufactured: 06/27/2019
• 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: 52 YR
• Patient Sex: Female