FDA Adverse Event
Injury
Summary report: N
ENTERRA
MDR report key: 2911981
·
Received January 11, 2013
Report
- Report Number
- 3004209178-2013-00499
- Event Type
- Injury
- Date Received
- January 11, 2013
- Report Date
- July 18, 2022
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO
- Product Code
- LNQ
- PMA / PMN Number
- H990014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD; PRODUCT ID 435135, SERIAL# (B)(4), IMPLANTED: (B)(6) 2007, PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT'S IMPLANTABLE NEUROSTIMULATOR (INS) WASN'T SITTING "QUITE RIGHT" IN THE POCKET. IN THE PAST MONTH, ONE OF THE PATIENT'S LEADS HAD COME LOOSE AND IT WAS POKING AGAINST HER SKIN. THE REPORTER INDICATED THAT THE PATIENT HAD LOST 20 POUNDS AND WAS ALREADY A 'THIN' PERSON. THE PATIENT WANTED THE DEVICE REMOVED. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 16715 | ENTERRA | INTESTINAL STIMULATOR | LNQ | MDT PUERTO RICO OPERATIONS CO | 3116 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention | "SEE H10...."| SEE H10 |