FDA Adverse Event
Injury
Summary report: N
ENTERRA
MDR report key: 1953814
·
Received January 4, 2011
Report
- Report Number
- 3007566237-2011-00008
- Event Type
- Injury
- Date Received
- January 4, 2011
- Date of Event
- December 28, 2010
- Report Date
- December 28, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LNQ
- PMA / PMN Number
- H990014
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PT HAD A REVISION TO REPLACE A BROKEN LEAD. INITIALLY, THE IMPEDANCE MEASUREMENTS WERE >800 OHMS BUT WHEN THE NEUROSTIMULATOR WAS PLACED IN THE POCKET THIS ISSUE WAS CORRECTED. IMPEDANCE MEASUREMENT ELECTRODE COMBINATION 0 TO 1 WAS >4000 OHMS BUT THAT COMBINATION WAS NOT GOING TO BE USED. UNABLE TO F/U WITH THE CONTACT INFORMATION PROVIDED HENCE NO ADDITIONAL INFORMATION WAS OBTAINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENTERRA | LNQ | MEDTRONIC NEUROMODULATION | 3116 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | LEAD: MODEL 4351, LOT# UNK| EXPLANTED:| IMPLANTED:| EXPLANTED:| LEAD: MODEL 4351, LOT# UNK| IMPLANTED: |