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

Model Number 8637-40

Device Problems Fluid/Blood Leak (1250); Occlusion Within Device (1423); Material Integrity Problem (2978)

Patient Problems Myocardial Infarction (1969); Overdose (1988); Pain (1994); Therapeutic Effects, Unexpected (2099); Complaint, Ill-Defined (2331); Loss of consciousness (2418)

Event Date 05/08/2017

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 8709, serial#: (b)(4), implanted: (b)(6) 2012, product type: catheter.Other relevant device(s) are: product id: 8709, serial/lot #: (b)(4), ubd: 03-dec-2012, udi#: (b)(4).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 an unknown dose and concentration via an implantable pump for non-malignant pain.It was reported that the patient recently had a pump replacement and there had been a pinch/kink in the catheter.The event date was noted to be (b)(6) 2018.This was realized after the patient had an overdose since it had unpinched.It was noted the patient was under anesthesia when the event occurred.There had been an x-ray and ct scans, but it had not been noticed.The patient was in the hospital for about a month and was now out and in rehab.The patient was "never really right" after the surgery and the following day she was out of it.No further issues were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer.It was reported that there was not an issue with the pump.The patient had pump replacement due to normal battery depletion and when the surgeon did the replacement, they found the catheter had a fracture, which meant the morphine was leaking in the patient's abdomen for probably a year or so.The patient was complaining about pain and they were upping the morphine from 0.3 to 0.7 because the morphine was not getting into the patient's spinal column, because it was leaking and her body was "aborting" it, but not all of it.The hcp fixed the fracture during the replacement surgery and the morphine would go into the patient's spinal cord and the hcp consulted with the patient's pain doctor to see if it would be safe to keep at the dose, since the patient was not getting the medication before, and the pain doctor said it was fine and it was a low dose and it was not a problem and the patient was sent home that afternoon.The patient overdosed in the middle of the night on (b)(6) 2018, did not wake up, had a mild heart attack, and had to rush to the emergency room (er).The er doctor had to use narcan on the patient.The surgeon requested the manufacturer representative turn the pump down and the order was cancelled by the pain doctor and no representative was sent out.The er hcp demanded that the pump was turned down.The pain clinic was contacted to have someone turn the pump down because the hcp in charge was not comfortable with that level of morphine while they were trying to get her kidney to functioning level and the order went through and the pump was turned down.Medication was 0.3.A "couple of weeks ago," relative to (b)(6)2018, the patient was in rehab and was released from the hospital without turning the pump up again, and no prescription for pain, so the pain came back and she had underlying pain and had spinal stenosis and the pain was unbearable.The patient was turned down to non-therapeutic level and the hcp at the nursing home called the manufacturer to request a manufacturer representative to come out and turn up the pump.The manufacturer representative never showed up and no one gave a reason why and the pain center did not know what was happening.They took the patient to the pain clinic to get the pump turned up.It was thought someone had cancelled the representative appointment.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: 7574130
• MDR Text Key: 110247379
• Report Number: 3004209178-2018-12747
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2018

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: 10/14/2019
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/04/2018
• Initial Date FDA Received: 06/06/2018
• Supplement Dates Manufacturer Received: 06/20/2018
• Supplement Dates FDA Received: 06/22/2018
• Date Device Manufactured: 04/17/2018
• 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; Required Intervention
• Patient Age: 80 YR