FDA Adverse Event
Injury
Summary report: N
SWIFT-LOCK ANCHOR
MDR report key: 2080392
·
Received April 22, 2011
Report
- Report Number
- 1627487-2011-02485
- Event Type
- Injury
- Date Received
- April 22, 2011
- Date of Event
- March 25, 2011
- Report Date
- March 25, 2011
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- K092371
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, 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
DEVICE 3 OF 3. REFERENCE MFR REPORT: 1627487-2011-02483 AND 1627487-2011-02484.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SWIFT-LOCK ANCHOR | SPINAL CORD STIMULATION LEAD ACCESSORY | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 1192 | 3255039 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 94 YR | Hospitalization| R |