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

Model Number 8637-40

Device Problem Failure to Interrogate (1332)

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

Event Date 01/24/2017

Event Type  malfunction  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a healthcare professional (hcp) regarding a patient who was receiving preservative free morphine [2.0 mg/ml] at a dose of 0.4998 mg/day at simple continuous infusion mode via an implantable pump for non-malignant pain.It was reported on (b)(6) 2017 that the hcp was getting the same error code on both physician programmers when trying to interrogate the patient¿s pump.The error code was 08:08:f8:dc-666.The programmers were turned off/back on and the application cards were re-seated as troubleshooting but this did not resolve the event as both programmers were still showing the same error message.The hcp was transferred to repair.On (b)(6) 2017 the hcp called to get replacement physician programmers and was redirected to replace the application cards.No symptoms were reported.Additional information was received from a manufacturer¿s representative on 2017-jan-26.It was reported that the representative met with the hcp and patient.He could not interrogate the pump.He tried a programmer with an older card as well without success.The representative tried to check the pump status with the patient¿s personal therapy manager (ptm) and that was successful.It was indicated that the patient was able to give herself boluses but noticed that the refill date showed ¿04 jan 00.¿ the representative then tried to re-read the pump after reading it with the ptm and saw that the error code changed slightly to 08:08:f8:0c-666.The representative also tried programming the pump to minimum rate to see if telemetry would complete and got the same code.A printed session data report for when the pump was examined on (b)(6) 2017 at 15:55 which showed that before the change on (b)(6) 2017 (implant date) the pump was in shelf state and contained water at minimum rate infusion mode with the last change being on (b)(6) 2016 at 06:40.The pump status after the update on (b)(6) 2017 at 16:11 and reflected that the drug information was updated (see above) and that the patient activated dose was set at 0.0419 mg with a lockout interval of 01:00 h:m, a dose restriction interval of 1/01:00 h:m, and with 8 maximum activations/day.It was seen on the report that the logs had not been read.Additional information was received from the representative on 2017-jan-27.It was again reported that they tried multiple times to interrogate the pump with three different physician programmers, one of which was the representative¿s.The cause of the incorrect refill date displaying on the ptm was not determined and had not been resolved.The error codes/telemetry issue also had not been resolved.

Manufacturer Narrative

Synchromed ii memory reset.Correction number pending.

Event Description

Additional information was received on (b)(6) 2017.It was reported that the problem was solved non-invasively and that essentially a script was developed for use by a labview programmer, and was brought out to the field to correct the error/issue.This action was conducted on (b)(6) 2017 and was successful as it resolved the issue reported and helped the patient regain control of her pain therapy.It was indicated that the time of the report the pump was able to be read normally again with a physician programmer.It was noted that the patient was a military/army veteran who served overseas.

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 clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6298816
• MDR Text Key: 66508784
• Report Number: 3004209178-2017-02468
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169508156
• UDI-Public: 00643169508156
• 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: Nurse
• Remedial Action: Repair
• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/28/2018
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2017
• Date Device Manufactured: 12/07/2016
• 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: 45 YR