FDA Adverse Event
Malfunction
Summary report: N
EON
MDR report key: 2903344
·
Received December 14, 2012
Report
- Report Number
- 1627487-2012-06937
- Event Type
- Malfunction
- Date Received
- December 14, 2012
- Date of Event
- November 19, 2012
- Report Date
- November 19, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Product Problem
- 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 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
DEVICE 2 OF 3. REFERENCE MFR REPORT#: 1627487-2012-06936, 06938. THE PT HAS AN EXTENSION FOR OFF-LABEL USE. IT WAS REPORTED INVALID CONTACTS WERE FOUND. X-RAYS REVEALED THE PT'S EXTENSION IS FRACTURED. THERE IS ALSO AN UNK ISSUE RELATED TO BOTH OF THE PT'S IPG'S. THE PT WILL UNDERGO SURGICAL INTERVENTION TO ADDRESS THE ISSUES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EON | SCS IPG | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3716 | 3346030 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 18 YR | Required Intervention | SCS LEADS: MODEL 3169 (4)| SCS EXTENSIONS: MODEL 3346 (2)| IMPLANT:| IMPLANT: |