FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 3891889
·
Received June 10, 2014
Report
- Report Number
- 1627487-2014-23392
- Event Type
- Injury
- Date Received
- June 10, 2014
- Date of Event
- May 19, 2014
- Report Date
- May 16, 2014
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- GZB
- 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 INFO RELATED TO THE PT'S MED HISTORY AND IS UNABLE TO FORM AN OPINION AS TO RELEVANCY OF THE PT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PT'S PHYSICIAN REGARDING MED HISTORY.
Description of Event or Problem · 1
DEVICE 2 OF 2. REFERENCE MFR. REPORT# 1627487-2014-23391. IT WAS REPORTED DUE TO LEAD MIGRATION, THE PT UNDERWENT SURGICAL INTERVENTION WHERE HER LEADS WERE REPLACED WITH NEW ONES. IN ADDITION, THE PHYSICIAN ELECTIVELY REMOVED AND REPLACED THE PT'S IPG. THE PT REPORTED EFFECTIVE STIMULATION COVERAGE POSTOPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 341048 | OCTRODE | SCS LEAD | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 3186 | 56651 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Other | SCS IPG, MODEL 3716| IMPLANT DATE: |