FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 2921756
·
Received January 14, 2013
Report
- Report Number
- 1627487-2013-13069
- Event Type
- Injury
- Date Received
- January 14, 2013
- Date of Event
- December 20, 2012
- Report Date
- December 20, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SJM HAS LIMITED INFORMATION RELATED TO THE PT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
THE PT HAD TWO LEADS FROM THE SAME LOT NUMBER. IT WAS REPORTED THE PT HAD A SURGICAL PROCEDURE TO IMPLANT AN IPG. DURING THE PROCEDURE, THE PT'S LEADS WERE INADVERTENTLY PULLED FROM THEIR ORIGINAL LOCATION. THE LEADS WERE EXPLANTED AND REPLACED WITH NEW LEADS. THE PT HAD EFFECTIVE STIMULATION COVERAGE POSTOPERATIVE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 19957 | OCTRODE | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3186 | 3777307 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 27 YR | Required Intervention | SCS IPG: MODEL 3788| IMPLANT DATE: |