FDA Adverse Event
Injury
Summary report: N
ENTERRA
MDR report key: 2172342
·
Received June 23, 2011
Report
- Report Number
- 3004209178-2011-04758
- Event Type
- Injury
- Date Received
- June 23, 2011
- Date of Event
- January 1, 2011
- Report Date
- May 27, 2011
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LNQ
- PMA / PMN Number
- HDE99015
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
- Health Professional
- N
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PATIENT EXPERIENCED NAUSEA, DIARRHEA, AND INCREASED PAIN. SHE HAD AN ENDOSCOPY AND HER HEALTH CARE PROFESSIONAL NOTICED THAT A LEAD MAY HAVE ERODED THROUGH THE LINING OF THE STOMACH WALL. A LEAD REPLACEMENT WAS PLANNED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENTERRA | LNQ | MEDTRONIC PUERTO RICO OPERATIONS CO., JUNCOS | 3116 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Female | EXPLANTED:| EXPLANTED:| IMPLANTED:| IMPLANTED:| LEAD: MODEL 4351, LOT# NHT010397N.| LEAD: MODEL 4351, LOT# NHT010398N.| IMPLANTED:| LEAD: MODEL 4351, LOT# NHT010398N| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 4351, LOT# NHT010397N |