FDA Adverse Event
Injury
Summary report: N
ENTERRA
MDR report key: 1902243
·
Received November 15, 2010
Report
- Report Number
- 3004209178-2010-09497
- Event Type
- Injury
- Date Received
- November 15, 2010
- Date of Event
- July 1, 2010
- Report Date
- November 1, 2010
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LNQ
- PMA / PMN Number
- HDE99015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, 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 WITH SYMPTOMS THAT INCLUDED NAUSEA, VOMITING, AND CRAMPING. STIMULATION STOPPED APPROX TWO WEEKS PRIOR. THE PT'S STATUS WAS FAIR. IT LATER WAS REPORTED THAT THE DEVICE WAS REPLACED ON (B)(6) 2010, BUT THAT THE PT STILL WAS HAVING TROUBLE WITH THE SYSTEM AND STILL WAS NOT ABLE TO EAT. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
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 | 45 YR | Required Intervention | LEAD: MODEL 4351, LOT # NHT002194N| IMPLANTED:| LEAD: MODEL 4351, LOT # NHT002195N| EXPLANTED:| EXPLANTED:| IMPLANTED: |