MAUDE Adverse Event Report: MEDTRONIC MINIMED MINIMED ++ SILHOUETTE INFUSION SET 4; SET, ADMINISTRATION, INTRAVASCULAR

Model Number MMT-371

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); No Code Available (3191)

Event Type  Injury  

Event Description

Per (b)(6), field nurse email: ¿i spoke with (b)(6) and she has changed the subcutaneous remodulin site 3 times in a month.She feels like maybe she is not receiving her remodulins well with the silhouette system.Since stated the silhouette she has noticed her skin is harder around site.Denies signs of infection.Says she has doctor visit scheduled for next week and plans to address feelings of increased shortness of breath.¿ no other information known.Reported to (b)(6) by health professional.

• Brand Name: MINIMED ++ SILHOUETTE INFUSION SET 4
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): MEDTRONIC MINIMED
• MDR Report Key: 10179319
• MDR Text Key: 196135059
• Report Number: MW5095120
• Device Sequence Number: 3
• Product Code: FPA
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/16/2020
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: MMT-371
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1