FDA Adverse Event
Malfunction
Summary report: N
ENTERRA
MDR report key: 2053613
·
Received March 1, 2011
Report
- Report Number
- 3004209178-2011-01523
- Event Type
- Malfunction
- Date Received
- March 1, 2011
- Date of Event
- February 21, 2011
- Report Date
- February 22, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- LNQ
- PMA / PMN Number
- H990014
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING AM IMPLANT PROCEDURE, THE PHYSICIAN NOTED THAT THERE WAS A GAP OF APPROX 1 MM BETWEEN THE END OF THE LEAD AND THE CONNECTOR IN THE HEADER BLOCK. HIGH IMPEDANCES WERE MEASURED. HE NOTED THAT THE LEADS LOOKED PERFECT IN THE STOMACH AND WAS RELUCTANT TO REPLACE THE LEADS, SO HE REPLACED THE NEUROSTIMULATOR. THE LEADS THEN WENT IN THE DEVICE AND IMPEDANCES WERE NOTED AS OKAY (700 OHMS). ADD'L INFO WAS REQUESTED.
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 | EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 4351, LOT # UNK| LEAD: MODEL 4351, LOT # UNK| IMPLANTED: |