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); Use of Device Problem (1670); Insufficient Flow or Under Infusion (2182); Application Program Problem (2880)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 11/30/2019

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 8835, serial#: unknown, product type: programmer, patient.Other relevant device(s) are: product id: 8835, serial/lot #: unknown.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient and a healthcare professional (hcp) via a manufacturer's representative (rep).The patient was receiving an unknown concentration of bupivacaine at 1.999mg/day and an unknown concentration of morphine at 0.1199mg/day via an implantable infusion pump for non-malignant pain.It was reported that patient's hcp turned up the infusion rate.The non-critical alarm went off and the patient programmer (ptm) said "low reservoir." the critical alarm started going off because the pump was empty.The pump had been empty since (b)(6) 2019.The pump was flushed with saline, and then filled with morphine on (b)(6) 2019.After the refill the patient wasn't getting any relief from the pump.The volume of the reservoir was going to be checked.The patient reported that there is a ptm bolus request that is not accurate.The ptm will show that a bolus is delivered when they haven't been requested.The refill date on the ptm was also not accurate.No symptoms were reported.It was unknown if the issue was resolved, and the patient's status was noted as "alive-no injury." no further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from an hcp on 2019-dec-24.It was reported that the instance of the patient being given a bolus even though one had not been requested was not confirmed to have occurred.The cause of the empty pump was administrative, and the pump was refilled.The lack of pain relief was resolved.

• 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: 9460265
• MDR Text Key: 179331973
• Report Number: 3004209178-2019-23705
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169630505
• UDI-Public: 00643169630505
• 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,consum
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 01/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2020
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2019
• Date Device Manufactured: 05/07/2019
• 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 Age: 54 YR
• Patient Weight: 74