FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 3820010
·
Received May 14, 2014
Report
- Report Number
- 1627487-2014-05343
- Event Type
- Injury
- Date Received
- May 14, 2014
- Date of Event
- April 22, 2014
- Report Date
- April 22, 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 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
ON (B)(6) 2014, THE PATIENT UNDERWENT A TRIAL PROCEDURE. DURING THE PROCEDURE, THE DOCTOR TOOK 45 MINUTES TO MAKE ATTEMPTS TO ACCESS THE CERVICAL AND THORACIC AREAS. THE DOCTOR WAS EVENTUALLY ABLE TO ACCESS THE THORACIC AREA BUT STRUGGLED TO DO SO. THE PATIENT EXPERIENCED PAIN ONCE THE LEAD WAS ADVANCED. AS A RESULT, THE PROCEDURE WAS ABANDONED. POST-OP, THE PATIENT WAS ASSESSED AND NO LOSS OF FUNCTION OR LONG TERM PAIN WERE PRESENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 288900 | OCTRODE | SCS LEAD | GZB | ST JUDE MEDICAL NEUROMODULATION | 3086 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |