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

Model Number 8637-40

Device Problems Difficult to Interrogate (1331); Unstable (1667)

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

Event Date 04/01/2016

Event Type  malfunction  

Event Description

Information was received from a consumer via a company representative regarding a patient receiving medication via an implantable pump for non-malignant pain.Three or four months ago ((b)(6) of 2016) the personal therapy manager (ptm) was indicating that the patient was locked out from receiving a bolus; the bolus was unexpectedly declined.The patient believed she was being locked out of intended patient activated (pa) boluses.The ptm beeps for quite a while, and sometimes beeps for just 2-3 beeps when initiating a bolus dose.The patient has lost 10 pounds in the last two months ((b)(6) of 2016), so the pump is turned a little in the pump pocket area and was not positioned properly in the pocket.It was thought that this may be one of the reasons why there were communication issues between the pump, physician programmer, and ptm.On (b)(6) 2016 there were telemetry issues when interrogating the pump for the event logs.Telemetry was eventually successful.After reviewing the palogs and ptm technical report it was confirmed that the patient was getting her boluses.The report showed a bolus denied for intl lockout that corresponded to a successful pa request (indicated by an 88 in the pa log from the technical report).The lockout was due to the lockout interval and uplink interference.An antenna was provided to the patient.There were no medical symptoms 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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5906369
• MDR Text Key: 53099109
• Report Number: 3004209178-2016-17681
• Device Sequence Number: 1
• Product Code: LKK
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 08/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2015
• 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: 08/01/2016
• Date Device Manufactured: 01/23/2014
• 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: 58 YR