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

Model Number 8637-40

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

Patient Problems Fever (1858); Low Blood Pressure/ Hypotension (1914); Overdose (1988); Complaint, Ill-Defined (2331); Shaking/Tremors (2515)

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 healthcare provider regarding a patient receiving unknown drug via an implanted pump.The indication for use was spinal pain.It was reported the patient was in critical care in the icu and needed their pain pump turned off/down.It was noted the patient's symptoms started on thursday ((b)(6) 2018) at 10:00am.The patient had a fever, was shaking all over, had a low blood pressure, and was tacky.The admitting diagnosis was questionable septicemia around the device, but when the patient was discharged on (b)(6) 2018 the diagnosis was potential unintentional overdose, but they still didn't know what the problem actually was.The patient was given 4 bags of fluids and antibiotics in the hospital, but nothing changed.The hcp wasn't sure if the patient had been given too much flexibility with boluses or took too many orals.It was noted the hcp was also giving the patient oral narcotics in decreasing amounts in proportion to the increased pump dose.A manufacture representative lowered the patient's dose was they were in the icu, but did not come out and talk about what was happening.The patient's next appointment was scheduled for (b)(6) 2018.The patient's weight was not known off hand.Additional information confirmed that the reason the patient was in critical care was an overdose from the pump and oral narcotics.It was noted the pump was programmed at a certain rate and the patient was issued 4 boluses per day, which the patient usually used before physical therapy.The patient's hcp increased the patient's dose and concentration and prescribed the patient oral narcotics, and the patient was still giving themselves boluses.The hospital confirmed that they ruled out any type of infection or sepsis with blood cultures, and started the patient on a narcan drip.It was also confirmed that a manufactures representative had turned the pump to kvo rate but did not explain the situation.It was noted the final diagnosis was unintentional overdose.The overdose was now resolved and the patient returned to baseline.

• 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: 7538917
• MDR Text Key: 109095233
• Report Number: 3004209178-2018-11705
• 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: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2018
• 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: 04/26/2018
• Date Device Manufactured: 05/09/2017
• 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 Outcome(s): Hospitalization; Life Threatening