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

Model Number 8637-20

Device Problems No Audible Alarm (1019); Pumping Stopped (1503); Application Program Problem (2880); Data Problem (3196)

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

Event Date 01/07/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: a810, product type: software.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a foreign healthcare professional (hcp) via a manufacturer representative regarding a patient receiving intrathecal clonidine 1,000.0 mcg/ml at 74.9 mcg/day via an implantable pump.The indication for use was not reported.It was reported that when the customer interrogated the pump on (b)(6) 2020 at 15:15, the service codes 101 (a pump reset has occurred.Infusion is set to minimum rate.), 87 (potential loss of therapy : the pump is in safe mode.Therapy is running in minimum rate.), and 116 ( potential underdose : due to pump memory error, myptm may not accurately access the myptm settings.The issue will be resolved at update.) appeared on the tablet screen.The customer then closed the session.The patient did not show any withdrawal symptoms at the interrogation.No alarm was reported to go off.After contacting the device manufacturer, the device manufacturer technical services department recommended that they clear the warnings and program the pump according to the therapeutic needs of the patient.The pump was therefore re-interrogated and reprogrammed on (b)(6) 2020 at ¿15:20¿ [logs indicated that the pump was actually re-programmed around 15:32 to 15:33].The patient was observed for some time, but no sign of underdose or overdose was reported.Logs showed: critical alarm - pump defaulted to minimum rate (07) on (b)(6) 2020 at 15:16 critical alarm - pump reset due to firmware error (2c) on (b)(6) 2020 at 15:16 critical alarm - pump reset (01) on (b)(6) 2020 at 15:16 critical alarm - pump defaulted to minimum rate (07) on (b)(6) 2020 at 15:32 pump motor stall recovery (1a) on (b)(6) 2020 at 15:33.No further complications were reported.

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: 9647827
• MDR Text Key: 176992447
• Report Number: 3004209178-2020-02191
• Device Sequence Number: 1
• Product Code: LKK
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 04/11/2020
• Date Device Manufactured: 05/15/2017
• 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: 43 YR