FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 4240480
·
Received October 30, 2014
Report
- Report Number
- 1627487-2014-26915
- Event Type
- Injury
- Date Received
- October 30, 2014
- Date of Event
- October 10, 2014
- Report Date
- October 10, 2014
- Manufacturer
- ST. JUDE MED - NEUROMODULATION
- Product Code
- GZB
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, 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 #3 OF 3. REFERENCE MFR. REPORT: 1627487-2014-26913 AND 26914. THE PATIENT REPORTED SHE UNDERWENT SURGICAL INTERVENTION TO REMOVE HER SCS SYSTEM BECAUSE SHE DID NOT LIKE THE SCS SYSTEM AND SHE DID NOT RECEIVE EFFECTIVE STIMULATION. IN ADDITION, THE IPG SITE WAS ALSO BOTHERING HER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 696633 | OCTRODE | SCS LEAD | GZB | ST. JUDE MED - NEUROMODULATION | 3183 | 176233 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Other |