FDA Adverse Event
Injury
Summary report: N
ENTERRA
MDR report key: 2231101
·
Received August 26, 2011
Report
- Report Number
- 3004209178-2011-06923
- Event Type
- Injury
- Date Received
- August 26, 2011
- Date of Event
- August 1, 2011
- Report Date
- August 12, 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
- NC, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEADS HAD "GONE BAD" AND NEEDED TO BE REPLACED SEVEN MONTHS AFTER IMPLANT. ADDITIONAL INFO HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
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 | Female | Required Intervention | EXPLANTED.| EXPLANTED.| IMPLANTED.| IMPLANTED.| LEAD: MODEL 4351, LOT# NHT013577N.| LEAD: MODEL 4351, LOT# NHT013578N.| EXPLANTED:| LEAD: MODEL 4351, LOT# NHT013577N| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 4351, LOT# NHT013578N |