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

Model Number 8637-20

Device Problems Inappropriate or Unexpected Reset (2959); Data Problem (3196)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/12/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: a810, serial#: unknown, product type: software.Other relevant device(s) are: product id: a810, serial/lot #: unknown.This device issue is known and documented in the labeling per ma04279a071 ¿ n¿vision clinician programmer with software synchromed ii infusion systems.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a consumer via a company representative (rep) regarding a patient receiving intrathecal unknown morphine (concentration and dose unknown) via an implanted pump for malignant pain.It was reported the patient saw an unspecified error code on the personal therapy manager (ptm).The pump was read and error codes 100 (motor stalled) and 87 (pump is in safe mode) were displayed - reset and ptm data lost.It was reviewed the pump was now at minimum rate, so patient was not getting therapy - not just ptm boluses.Additional information received from the rep indicated the pump defaulted to minimum rate and firmware error.It was noted after the rep updated the correct infusion, he did silence the active alarms.Patient symptoms were not reported.Additional information was received from a healthcare provider (hcp) via a company representative (rep) on 2021-aug-23 indicated the cause of the error codes and firmware error was not determined.The patient was reprogrammed by the provider and they believed that this issue had been resolved.The patient was receiving intrathecal morphine 25 mg/ml at 0.158 mg/day.The long session report was provided and showed a pump memory error occurred and safe rate was in use after pump reset.A pump reset due to firmware error occurred on (b)(6) 2021.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 12370766
• MDR Text Key: 268248219
• Report Number: 3004209178-2021-12950
• 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
• Type of Report: Initial
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2020
• Device Model Number: 8637-20
• Device Catalogue Number: 8637-20
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2021
• Date Device Manufactured: 01/22/2019
• 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: 77 YR