FDA Adverse Event
Injury
Summary report: N
OCTRODE LEAD KIT, 60CM LENGTH
MDR report key: 7607355
·
Received June 15, 2018
Report
- Report Number
- 1627487-2018-05799
- Event Type
- Injury
- Date Received
- June 15, 2018
- Date of Event
- March 16, 2018
- Report Date
- June 15, 2018
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- GZB
- UDI-DI
- 05415067017246
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. THE MANUFACTURER DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
DEVICE 2 OF 2: REFERENCE MFR REPORT #1627487-2018-05798. IT WAS REPORTED THE PATIENT'S SCS SYSTEM WOULD NOT TO INCREASE AMPLITUDE SETTINGS. REPORTEDLY, DIAGNOSTIC TESTING OF THE FIRST LEAD IDENTIFIED HIGH IMPEDANCES ON ALL CONTACTS. REPROGRAMMING OF THE SECOND LEAD WAS UNABLE TO PROVIDE THE PATIENT WITH COMPLETED PAIN COVERAGE. AS A RESULT, SURGICAL INTERVENTION MAY BE UNDERTAKEN AS THE NEXT COURSE OF ACTION TO ADDRESS THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 447735 | OCTRODE LEAD KIT, 60CM LENGTH | SCS LEAD | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 3186 | 6006472 | 05415067017246 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR | Other | MODEL 1192(2), SCS ANCHOR| MODEL 3660, SCS IPG |