FDA Adverse Event
Malfunction
Summary report: N
ENTERRA
MDR report key: 1800109
·
Received August 11, 2010
Report
- Report Number
- 3004209178-2010-06032
- Event Type
- Malfunction
- Date Received
- August 11, 2010
- Date of Event
- January 1, 2010
- Report Date
- July 13, 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 Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
THE PT HAD CONSTANT PAIN AND ACHINESS AT THE INS/LEAD SITES. THE INS WAS HITTING HER RIBCAGE AND SEEMED TO HAVE MIGRATED HIGHER IN HER ABDOMEN. IT APPEARED TO FLIP WHEN THE PT BENT OVER. SHE ALSO EXPERIENCED SHOCKING/JOLTING SENSATIONS. THE PT WAS IN FAIR CONDITION. FURTHER INFO IS BEING REQUESTED FROM THE HCP.
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 | 23 YR | IMPLANTED:| LEAD: MODEL 4351, LOT # NHT011320N| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 4351, LOT # NHT011316N |