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

Model Number 8637-40

Device Problems Excess Flow or Over-Infusion (1311); Improper or Incorrect Procedure or Method (2017)

Patient Problems Fall (1848); Overdose (1988)

Event Date 06/05/2017

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider (hcp) via a manufacturer representative regarding a patient who was receiving 15 mg/ml dilaudid at a dose of 9.997 mg/day and 5000 mcg/ml compounded baclofen at an unknown dose via an implantable pump for other chronic/intractable pain (trunk/limbs) and spinal pain.It was reported that the patient was refilled on (b)(6) 2017 and baclofen was added to the drug mixture.On (b)(6) 2017, the patient presented to the emergency room (er) with unspecified overdose symptoms.The representative stated that the drug may have been incorrect.The baclofen was supposed to be 5 mcg/ml, but was really 5 mg/ml.It was considered a sudden change in therapy/symptoms.It was stated that it appeared to be a drug mixing issue.The representative clarified that they believed the drug really was 5 mg/ml baclofen with dilaudid 15 mg/ml at 9.997 mg/day.They planned to program the pump to minimum rate until the patient¿s overdose symptoms resolved.It was confirmed that the programmer was showing about 30 mcg/day for minimum rate of baclofen.The patient¿s symptoms started around 7:30 to 8:30 pm on (b)(6) 2017.The patient was refilled and the patient gave himself a personal therapy manager (ptm) bolus.Shortly after, the patient fell back and hit his head.The patient was currently in the er, but they were going to transport the patient to a different facility.Additional information was received from a manufacturer representative on (b)(6) 2017.It was stated that the pump was filled with the incorrect concentration and programmed to the concentration that was filled.The patient was taken to a hospital was the actions/interventions taken.The representative was alerted on (b)(6) 2017.Upon the direction of the managing hcp, the representative went to the hospital on (b)(6) 2017 and reprogrammed the pump.The daily dose was set to minimum rate per the direction of the managing hcp.The cause of the incorrect drug placed in the pump was unknown.As of (b)(6) 2017, the patient was admitted to the hospital.The patient¿s weight at the time of the event was unknown.There were no further complications reported or anticipated.

Manufacturer Narrative

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

• 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: 6631229
• MDR Text Key: 77272932
• Report Number: 3004209178-2017-12518
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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 Assistant
• Type of Report: Initial,Followup
• Report Date: 06/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2016
• 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: 06/06/2017
• Date Device Manufactured: 12/16/2014
• 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: 48 YR