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

Model Number 8637-20

Device Problems Improper or Incorrect Procedure or Method (2017); Application Program Problem (2880)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/23/2018

Event Type  malfunction  

Manufacturer Narrative

Other relevant device(s) are: product id: 8840, serial# unknown, product type: programmer.Product id: 8870, serial# unknown, product type: software.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare provider via a manufacturing representative (rep) regarding a patient receiving an unknown dose and concentration via an implantable pump for non-malignant pain.It was reported the patient was refilled the day before ((b)(6) 2018) and had a concentration change and bridge bolus.After the update, the healthcare provider noticed they had forgotten to change the reservoir volume, so they updated it to 20 milliliters (mls) and updated the pump.The pump printout showed the correct 20 ml volume but showed a refill date of (b)(6) 2018 along with a low and empty reservoir alarm.This was not noticed right away.The patient tried to use their ptm and saw the empty reservoir code.The patient was brought back into the office and at that point the reservoir volume was 19.6 mls.Technical services assisted the healthcare provider programming the pump to 10 mls and then back to 19.6 mls to force the programmer to update all the refill parameters.This updated the alarm date to (b)(6) 2018 and cleared the alarms, resolving the issue.It was verified the healthcare provider was using up-to-date software for the clinician programmer (version aau).No further complications were reported or anticipated.

• 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: 7464542
• MDR Text Key: 107194646
• Report Number: 3004209178-2018-09330
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169530119
• UDI-Public: 00643169530119
• 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
• Type of Report: Initial
• Report Date: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2019
• 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: 04/24/2018
• Date Device Manufactured: 11/15/2017
• 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 Age: 64 YR