MAUDE Adverse Event Report: MEDTRONIC ENGINEERING AND INNOVATION CENTER (MEIC) ENDOSCOPY PILL CAMERA SB3; ELECTRODE, PH, STOMACH

Patient Problems Ulcer (2274); Bowel Perforation (2668); Foreign Body In Patient (2687)

Event Date 10/12/2012

Event Type  Injury  

Event Description

Back on (b)(6) 2012, i've swallowed an endoscopy pill camera capsule, and it was retained.The surgeons over 3 hospitals in australia tried to remove "it 27" over 9 1/2 years.(b)(6) 2022, i had most of my bowel removed.The endoscopy camera capsule was removed at the time.It was broken in 2 pieces outside of my bowel in my pelvis area.It has been lying in that area since 2018 when the surgeon lasts seen it.I've reached out medtronic's, and they were stunned with what happened.The surgeons, over the years, failed to report the matter to medtronic's.The director of medtronic has spoken numerous times to me a discussion about the medical care over a year and wanted too hear from me my story.They finally removed the endo pill-cam but failed to send it off the manufacturer.The surgeon took a picture of it instead and given it to me.Over the years, i was very unaware that this device was killing me and i've started to ulcerate throughout bowel.

• Brand Name: ENDOSCOPY PILL CAMERA SB3
• Type of Device: ELECTRODE, PH, STOMACH
• Manufacturer (Section D): MEDTRONIC ENGINEERING AND INNOVATION CENTER (MEIC)
• MDR Report Key: 18394362
• MDR Text Key: 331398771
• Report Number: MW5149549
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Other; Required Intervention; Life Threatening
• Patient Age: 29 YR
• Patient Sex: Male
• Patient Weight: 75 KG
• Patient Race: White