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

Model Number 8637-40

Device Problems Use of Device Problem (1670); Insufficient Flow or Under Infusion (2182)

Patient Problems Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Complaint, Ill-Defined (2331); Chest Tightness/Pressure (2463)

Event Date 07/12/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient who was receiving morphine at unknown dose and concentration via intrathecal drug delivery pump.The indication for use was noted as spinal pain.It was reported that the patient's pump was implanted in (b)(6) and he lived in the (b)(6).The patient returned to (b)(6) every 2 months for an appointment with his hcp.Due to a problem with the healthcare provider (hcp) office obtaining medication and scheduling his pump was not refilled, alarmed and went empty.After going empty, the patient was hardly breathing, his pressure skyrocketed, he nearly died and the hcps at the hospital in the (b)(6) were very upset.After the patient recovered his breathing, pressure skyrocketed, really bad, he told the hcp he chose to suffer in bed rather than have that.He still suffered with breathing problems, his breath got low and he felt like his chest had bricks on top of it.His pump was alarming because he chose to stop having the pump filled.He had gone back to h is hcp to have the pump alarm silenced however the pump started alarming again within a couple of weeks.It beeped 3 times and the patient had heard other tones since it was going empty and became empty.The event date was (b)(6) 2018.There were no further complications reported at this time.

Manufacturer Narrative

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

Event Description

Additional information was received from a hcp.It was reported that the hcp did have the medication.The patient had not been seen since (b)(6) 2019.There were no further complications reported at this time.

• 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: 8326366
• MDR Text Key: 135735112
• Report Number: 3004209178-2019-02849
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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,Followup
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2019
• Date Device Manufactured: 11/28/2016
• 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; Life Threatening
• Patient Age: 44 YR
• Patient Weight: 98