FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 4252994
·
Received November 12, 2014
Report
- Report Number
- 1627487-2014-24368
- Event Type
- Injury
- Date Received
- November 12, 2014
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- GZB
- PMA / PMN Number
- P010032
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AN 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: 1627487-2014-24367. THE PATIENT REPORTED EXPERIENCING PAIN AT THE IPG SITE AND INEFFECTIVE STIMULATION. THE PATIENT REPORTED LOSING A SIGNIFICANT AMOUNT OF WEIGHT AFTER THE IMPLANT; AS A RESULT HIS IPG IS SUPERFICIAL AND HE EXPERIENCES DISCOMFORT. THE PATIENT ALSO REPORTED NOT USING HIS SYSTEM APPROXIMATELY 2-3 YEARS AGO DUE TO THE INEFFECTIVE STIMULATION AND DESIRES TO HAVE THE SYSTEM EXPLANTED. THE PATIENT IS TO CONSULT THE PHYSICIAN FOR THE NEXT COURSE OF ACTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 729754 | OCTRODE | SCS LEAD | GZB | ST. JUDE MEDICAL - NEUROMODULATION | 3186 | 176399 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |