FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 4253002
·
Received November 12, 2014
Report
- Report Number
- 1627487-2014-05774
- Event Type
- Injury
- Date Received
- November 12, 2014
- Date of Event
- October 21, 2014
- Report Date
- October 21, 2014
- Manufacturer
- ST. JUDE MED - 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 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. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
DEVICE 2 OF 2. REFERENCE MFR. REPORT#: 1627487-2014-05773. ON 10/21/2014, THE PATIENT UNDERWENT A TRIAL PROCEDURE AND RECEIVED TWO LEADS. LATER IN THE DAY, EFFECTIVE THERAPY WAS NO LONGER PRESENT DUE TO THE LEADS MIGRATING OUTSIDE OF THE PATIENT. THE PATIENT'S SPOUSE WAS ONLY ABLE TO FIND ONE OF THE LEADS. IN TURN, THE PATIENT'S DOCTOR ADVISED HIM TO CLEAN AND APPLY AN ADHESIVE BANDAGE (BAND-AID) TO THE INCISION SITE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 729658 | OCTRODE | SCS LEAD | GZB | ST. JUDE MED - NEUROMODULATION | 3086 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |