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

Model Number 8637-20

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

Patient Problems Fatigue (1849); Overdose (1988); Sedation (2368); Loss of consciousness (2418)

Event Date 09/28/2017

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 regarding a patient receiving morphine, 1 mg/ml at 0.14 mg/day.The indications for use were non-malignant pain, peripheral causalgia and phantom limb pain.The healthcare provider reported overdose type symptoms following a refill and a bridge.Per the healthcare the patient was sleepy and sedated a few hours after the refill and bridge.The healthcare provider stated that the patient was on a narcan drip.The settings were reviewed with the healthcare provider as the new daily dose was significantly higher than the old 0.38 vs 0.14 mg/day.The old drug desired dose was programmed as 0.45 mg/day and that would be ~320% increase.It was confirmed the healthcare provider intended that amount.It was reviewed how to program to min rate mode and cancel the bridge so the healthcare provider could monitor the patient overnight.The healthcare provider stated that the bridge ran for ~7 hours and would extend the bridge to account for some of the 8 mg/ml drug in the system.No further patient complications were reported.

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 reported that the healthcare provider had stopped the pump due to the fact the patient was not responsive.The healthcare provider stated he stopped the pump 7 hours into the 24hr bridge bolus.It was discussed with the healthcare provider 0.131ml was delivered.The healthcare provider stated he is going to refill the pump today with 1mg/ml hydromorphone again.It was discussed that there is now 8mg/ml hydromorphone that has moved into the pump tubing and the removing system contents procedure and the healthcare provider would do this.No further patient complications were reported.

• 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: 6903926
• MDR Text Key: 87762637
• Report Number: 3004209178-2017-20326
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508149
• UDI-Public: 00643169508149
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2018
• 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: 10/04/2017
• Date Device Manufactured: 05/26/2017
• 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): Other
• Patient Age: 17 YR
• Patient Weight: 70