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

Model Number 8637-20

Device Problems Excess Flow or Over-Infusion (1311); Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182)

Patient Problems Memory Loss/Impairment (1958); Overdose (1988); Complaint, Ill-Defined (2331); Lethargy (2560)

Event Date 11/09/2017

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 professional (hcp) via a company representative regarding a patient receiving morphine (20 mg/ml at 2 mg/day) via an implanted pump.The indication for pump use was non-malignant pain.It was reported that the pump was possibly over-infusing as the patient had overdose symptoms that occurred with the last 2 pump refills.The episodes occurred right after the pump refills.The pump was refilled on (b)(6) 2017.Two weeks after the refill the patient had the episode.The pump was then refilled on (b)(6) 2018.Two days later ((b)(6) 2018) the patient noticed the overdose symptoms of being lethargic, ¿out of it¿, and memory loss.It was noted that there were ¿fumes aspirated¿ with the last 2 refills ((b)(6) 2017 & (b)(6) 2018).The patient heard the pump alarm every 20 minutes and the low reservoir was confirmed via the event logs on (b)(6) 2017, but there was no empty reservoir alarm.On (b)(6) 2018 the pump was programmed to minimum rate (.122mg/day).The event logs were confirmed as normal.No further complications have been reported as a result of this event.

Manufacturer Narrative

Device code (b)(4) is also applicable for this event and should have been included on the initial mdr.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information was received from a consumer via a manufacturer representative.The patient was receiving morphine and an unknown drug at unknown dose and concentration.It was reported that the patient was set to minimum rate because of concerns that she was getting overdose type symptoms infrequently.The clinic had the patient scheduled for drug removal on (b)(6) 2018.It was unknown if the issue resolved and the patient was "alive - no injury." 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: 7560290
• MDR Text Key: 109762327
• Report Number: 3004209178-2018-12334
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100831
• UDI-Public: 00643169100831
• 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
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2016
• 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: 08/08/2018
• Date Device Manufactured: 09/15/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: Z-1570-2014
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 83 YR