FDA Adverse Event
Injury
Summary report: N
ENTERRA
MDR report key: 5330766
·
Received December 28, 2015
Report
- Report Number
- 3004209178-2015-25672
- Event Type
- Injury
- Date Received
- December 28, 2015
- Report Date
- December 2, 2015
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- LNQ
- PMA / PMN Number
- H990014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID: 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. PRODUCT ID: 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, PRODUCT TYPE: LEAD. (B)(4).
Description of Event or Problem · 1
THE PATIENT REPORTED PAINFUL/SHOCKING STIMULATION SENSATION. SHE FEELS IT EVERY DAY. THE PATIENT HAD NO IDEA WHAT MAY HAVE CAUSED THIS EVENT. IT'S BEEN LIKE THIS SINCE INITIAL IMPLANT. ADDITIONAL INFORMATION WAS BEING REQUESTED FROM THE HCP REGARDING WHEN DID SHOCKING ISSUE START. FOLLOW UP WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS RECEIVED.
Description of Event or Problem · 1
ADDITIONAL INFORMATION RECEIVED FROM THE HEALTH CARE PROVIDER (HCP) REPORTED THAT THE PATIENT DID NOT RECEIVE SHOCKING FROM ALL FOUR IMPLANTS SINCE 2005-08-20 AND THE SHOCKING WAS VERY TEMPORARY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 853034 | ENTERRA | INTESTINAL STIMULATOR | LNQ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 3116 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00036 YR | Required Intervention |