ENTERRA
Report
- Report Number
- 3004209178-2020-03656
- Event Type
- Injury
- Date Received
- February 19, 2020
- Date of Event
- February 7, 2020
- Report Date
- April 17, 2020
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LNQ
- UDI-DI
- 00643169614246
- PMA / PMN Number
- H990014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
PRODUCT ID: 4351-35, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID: 4351-35, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
ADDITIONAL INFORMATION WAS RECEIVED FROM THE HCP. IT WAS REPORTED THAT THE DEVICE WAS SURGICALLY REPLACED/REVISED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS). IT WAS REPORTED THAT THEY RAN IMPEDANCES AND FOUND THE VALUES TO BE HIGH. THE HCP STATED THEY PROGRAMMED THE PATIENT USING C+ 2- TO AVOID THE HIGH IMPEDANCES AND SENT THE PATIENT FOR X-RAYS. THE FOLLOWING VALUES WERE PROVIDED: 2C 3703C >2000023 20000. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
ADDITIONAL INFORMATION RECEIVED FROM A HEALTHCARE PROVIDER (HCP). IT WAS REPORTED THAT THE LEAD WAS SURGICALLY REPLACED AND THE PATIENT IS DOING GREAT. NO FURTHER COMPLICATIONS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 193877 | ENTERRA | INTESTINAL STIMULATOR | LNQ | MEDTRONIC PUERTO RICO OPERATIONS CO. | 37800 | 00643169614246 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 35 YR | Required Intervention |