FDA Adverse Event
Injury
Summary report: N
OCTRODE
MDR report key: 3141822
·
Received May 28, 2013
Report
- Report Number
- 1627487-2013-12732
- Event Type
- Injury
- Date Received
- May 28, 2013
- Date of Event
- December 1, 2012
- Report Date
- May 2, 2013
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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. REF MFR REPORT #1627487-2013-12731. IT WAS REPORTED THE PT DID NOT RECEIVE PAIN RELIEF FROM THE SCS SYSTEM. THE PT ALSO REPORTED HE THEN DID NOT USE OR CHARGE THE IPG SYSTEM FOR FIVE MONTHS. AS A RESULT, THE IPG BATTERY IS DEPLETED. THE PT DOES NOT WANT ANY INTERVENTION TO ADDRESS THE ISSUE AT THIS TIME. NOTE: THE PT HAS TWO LEADS WITH THE SAME LOT NUMBER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 233233 | OCTRODE | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3186 | 3229445 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention | IMPLANT DATE:| SCS ANCHOR, MODEL 1192 (2) |