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

Model Number 8637-40

Device Problems Excess Flow or Over-Infusion (1311); Volume Accuracy Problem (1675)

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

Event Date 06/21/2018

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient regarding the personal therapy manager (ptm) used with the implantable drug infusion device.The drug being delivered was morphine (unknown) at an unknown dose and concentration.The reason for use was non-malignant pain.It was reported that an incorrect refill date was displaying on the ptm.The issue started on (b)(6) 2018.The ptm was used after the most recent refill.The pump "almost ran out, the alarm didn't go off, so i had it filled today." prior to the refill, the date read (b)(6) 2018, and now ptm reads (b)(6) 2018."supposedly the alarm went off but i didn't hear it, i just happened to look this weekend and it said i was out on (b)(6) 2018, so i got in today and had like 1.1 left, and had hardly anything left in there".The patient could not confirm the alarm went off, and did not indicate a code was seen on ptm, and did state later in call that alarm did not go off.It was reviewed that the date on the ptm needs to be checked by the healthcare professional (hcp) to determine the cause.It was also reviewed that it is possible the information did not update at the initial bolus request after refill/update and the ptm should still work as programmed.The patient did not have printout from refill to confirm next refill date.The patient was redirected to follow up with the hcp to address incorrect information on ptm.There were no symptoms reported.There were no further complications reported/anticipated.

Manufacturer Narrative

Patient weight was reported.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.

Event Description

Additional information was received from the hcp on 2018-jul-03.The hcp stated, ¿she may just didn¿t hear the alarm.Expected volume was (b)(6) ml.I aspirated (b)(6) ml so alarm should have occurred as it was set at (b)(6) ml.¿ it was reported that there was no volume discrepancy.¿either the pump failed to activate alarm at low volume or patient did not hear it.¿ the cause of the incorrect refill date was not known.¿either the ptm device is not reading correct (which is common complaints among patient) or she did not check ptm date.¿ they ¿will see if next refill gives her the same error or not.¿ the patient¿s weight was reported.The serial number of the ptm was unknown.There were no further complications reported/anticipated.

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: 7629514
• MDR Text Key: 112466567
• Report Number: 3004209178-2018-14106
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00643169100824
• UDI-Public: 00643169100824
• 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,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• Device Model Number: 8637-40
• Device Catalogue Number: 8637-40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/08/2018
• Date Device Manufactured: 09/09/2015
• 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
• Patient Age: 66 YR
• Patient Weight: 89