MAUDE Adverse Event Report: MEDTRONIC, INC. MYPTM; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8835

Device Problems Excess Flow or Over-Infusion (1311); Device Displays Incorrect Message (2591); Application Program Problem (2880); Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Information was received from a patient who was receiving dilaudid (unknown dose and concentration) for non-malignant pain.The patient stated that beginning 2015, the personal therapy manager (ptm) report showed that the ptm was used 15 times and she was locked out 5 times.The patient stated that the ptm was only actually used only 5 times.The patient noted that the ptm had a wrong date on it and the diary was shut off.The screen was showing a bolus going through when the ptm was not over her pump.On (b)(6) 2016, the patient repeated previous information indicating that the bolus machine had a wrong date.Reportedly the ptm would go off whether she held it to her implant or to her couch cushion as if it gave her a bolus.Information was later received from a consumer on (b)(6) 2016 regarding the patient; it was reported that the patient thought her ptm was setting boluses off on it's own and her insurance was being over billed.Additional information has been requested regarding device information, circumstances that led to lockouts and incorrect dates, symptoms experienced, steps taken to resolve the issue and whether the issue had been resolved, but it was not available at the time of this report.If additional information is received, the event will be updated.

• Brand Name: MYPTM
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 7000 central avenue ne rcw215; minneapolis MN 55432
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 5460494
• MDR Text Key: 39417429
• Report Number: 2182208-2016-00707
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8835
• Device Catalogue Number: 8835
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/29/2016
• Date Device Manufactured: 06/11/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 00046 YR