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

Model Number 8637-20

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cerebrospinal Fluid Leakage (1772); Headache, Lumbar Puncture (2186)

Event Date 10/18/2020

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: 8780, serial/lot #: (b)(4), ubd: 07-oct-2021, udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from healthcare professionals (hcps) and a company representative regarding a patient receiving hydromorphone (5 mg/ml at.5506 mg/day) and bupivacaine (5 mg/ml at.5506 mg/day) via an implanted pump.On (b)(6) 2020, a hcp reported that the patient heard the alarm beep twice 2 days ago and again yesterday, but the logs were normal; the patient was still able to use their ptm (personal therapy manager); and there was no volume discrepancy.The patient had the pump dose increased 1 week ago and was reporting having headaches that started 2-3 days ago.The reporting hcp was going to redirect the patient to the surgeon that placed the pump.Additional information was received on 23-oct-2020 from another hcp via a company representative who reported that the patient was admitted to the hospital due to a csf (cerebrospinal fluid) leak that he was being treated for and the patient had been experiencing headaches due to the csf leak.The patient reported hearing an alarm and the hcp heard the alarm as well.The alarm had been heard once a day but had not been heard yet today.The patient described the alarm as a series of beeps.The reporter in terrogated the pump with the logs and no alarms were noted.The alarms were played for the patient and he thought the alarm sounded like the pump alarms, but there were no alarm logs shown on the pump logs and the programming was accurate.

• 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: 10746675
• MDR Text Key: 213417048
• Report Number: 3004209178-2020-18799
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2021
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/23/2020
• Date Device Manufactured: 03/03/2020
• 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
• Patient Age: 49 YR