MAUDE Adverse Event Report: MEDTRONIC, INC./GIVEN IMAGING, INC PILLCAM; SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/29/2019

Event Type  malfunction  

Event Description

The pillcam has broken inside the colon of the reporter.The reporter has had several test and x-rays to show the broken pieces found in her colon.She has had follow up appointments with her doctor several times.She has been advised to have an additional colonoscopy and egd but, is uncomfortable with having it done since the pillcam broke and pieces are still retained in her colon.The reporter felt threaten with the doctor as she was advised to have a new colonoscopy that is when the doctor told her that the fragment could make a hole in her colon.On (b)(6) 2019 a medtronic representative contacted the reporter to ask questions regarding her health history.As the reporter had questions to the medtronic rep would not answer any.Reporter states she had questions about why medtronic thought the device broke or what material it was made of.Reporter has had a second opinion and has to pay additional cost out of pocket related to this incidence.

• Brand Name: PILLCAM
• Type of Device: SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE
• Manufacturer (Section D): MEDTRONIC, INC./GIVEN IMAGING, INC
• MDR Report Key: 10535079
• MDR Text Key: 207187811
• Report Number: MW5096618
• Device Sequence Number: 1
• Product Code: NEZ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/14/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 59