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

Model Number 8637-20

Device Problems Volume Accuracy Problem (1675); Insufficient Flow or Under Infusion (2182); Device Displays Incorrect Message (2591)

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

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 8835, serial#: (b)(4), product type: programmer, patient.Other relevant device(s) are: product id: 8835, serial/lot #: (b)(4), udi#: (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient who was receiving at morphine, unknown concentration at unknown dose via intrathecal drug delivery pump for non-malignant pain.It was reported that bolus was unexpectedly declined.Patient felt like she was not getting relief and she was in terrible pain.Patient reported her patient programmer (ptm) was malfunctioning and not giving her the bolus when it should.The ptm was giving her normal lockouts of 3 hours when it should deliver a bolus.Today she had refill and the healthcare professional (hcp) took out medication that should have been used up and to call the manufacturer for replacement ptm.Patient was having uplink issue and wanted a ptm replacement.Patient had a lot of medicine left in pump due to not being able to get her bolus's per patient.No further complications were reported.

Manufacturer Narrative

(b)(4).Ptm returned for analysis.Analysis found no significant anomaly.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.

• 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: 7660488
• MDR Text Key: 113457101
• Report Number: 3004209178-2018-14978
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2017
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2015
• 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