MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number NEU_UNKNOWN_PUMP

Device Problems Device Displays Incorrect Message (2591); Application Program Problem (2880)

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

Event Type  malfunction  

Event Description

It was reported that a patient¿s pump ran out of medication without warning ¿(b)(6) 2015.¿ the patient mentioned that the personal therapy manager was giving the wrong refill date and the screen then changed to display ¿code 8835 then a finger pointing to the ptm;¿ later the patient clarified that the ptm had been disabled by the healthcare professional (hcp) ¿because the patient was not using it enough.¿ the pump was used to infuse morphine (unknown).No outcome was reported for this event.Follow up was being conducted to obtain further information; if additional information is received a follow up report will be sent.

Manufacturer Narrative

Concomitant medical products: product id: 8835, serial# unknown, product type: programmer, patient.Product id: neu_ unknown_cath, serial# unknown, product type: catheter.(b)(4).

Manufacturer Narrative

(b)(4).

• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 120
• 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: 4868843
• MDR Text Key: 5864602
• Report Number: 3007566237-2015-01755
• 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,Followup
• Report Date: 06/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_UNKNOWN_PUMP
• Device Catalogue Number: NEU_UNKNOWN_PUMP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2015
• 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: 00059 YR