FDA Adverse Event
Injury
Summary report: N
ENTERRA
MDR report key: 2160623
·
Received July 7, 2011
Report
- Report Number
- 3004209178-2011-05165
- Event Type
- Injury
- Date Received
- July 7, 2011
- Date of Event
- January 1, 2011
- Report Date
- June 13, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LNQ
- PMA / PMN Number
- H990014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT (ONGOING ISSUES WITH VOMITING) AND WAS FEELING PAIN AT THE POCKET SITE. THE PT HAD HER ENTIRE SYSTEM EXPLANTED AND REPLACED ON (B)(6) 2011. THERE WERE NO ISSUES DURING THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENTERRA | LNQ | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 3116 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR | Required Intervention | IMPLANTED:| EXPLANTED:| LEAD: MODEL 4351, LOT# NHT004296N| LEAD: MODEL 4351, LOT# NHT004297N| EXPLANTED:| IMPLANTED: |