MAUDE Adverse Event Report: MEDTRONIC MINIMED MMT-515 PARADIGM INSULIN PUMP; PUMP, INFUSION, INSULIN

Model Number MMT-515LNAS

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Death (1802)

Event Date 07/13/2020

Event Type  Death  

Manufacturer Narrative

Currently it is unknown whether or not the device may have caused or contributed to the event as no product has been returned.The device will be returned for analysis and further information will follow once the analysis has been completed.No conclusion can be drawn at this time.

Event Description

Medtronic legal received information regarding the customer¿s passing and a previous help line contact from the attorney of the family.The information received on july 13, 2020 stated the following - reporter alleges the customer is deceased and that on (b)(6) 2020, the customer had contact with the medtronic help line and needed the transcript of that contact preserved.No further information was provided.

• Brand Name: MMT-515 PARADIGM INSULIN PUMP
• Type of Device: PUMP, INFUSION, INSULIN
• Manufacturer (Section D): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer (Section G): MEDTRONIC MINIMED; 18000 devonshire st.; northridge CA 91325 1219
• Manufacturer Contact: gerwin de graaff ; 18000 devonshire st.; northridge, CA 91325-1219 ; 8185464805
• MDR Report Key: 10312797
• MDR Text Key: 200015386
• Report Number: 2032227-2020-151021
• Device Sequence Number: 1
• Product Code: LZG
• UDI-Device Identifier: 00613994474117
• UDI-Public: (01)00613994474117
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: MMT-515LNAS
• Device Catalogue Number: MMT-515LNAS
• Device Lot Number: A000124485
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/13/2020
• Initial Date FDA Received: 07/23/2020
• Date Device Manufactured: 08/11/2008
• 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
• Treatment: FRN-MMT-326-RSVRUNOMED SET
• Patient Outcome(s): Death
• Patient Age: 39 YR
• Patient Weight: 175