FDA Adverse Event
Malfunction
Summary report: N
SWIFT-LOCK ANCHOR
MDR report key: 2191571
·
Received July 20, 2011
Report
- Report Number
- 1627487-2011-06002
- Event Type
- Malfunction
- Date Received
- July 20, 2011
- Date of Event
- June 21, 2011
- Report Date
- June 21, 2011
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- K092371
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- 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 DIFFERS TO THE PT¿S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
UPON EXPLANT OF A LEAD AT THE CONCLUSION OF THE TRIAL (B)(4), IT WAS REPORTED THAT THE LEAD ANCHOR WAS BROKEN. THE DAMAGE REPORTEDLY OCCURRED PRIOR TO THE DEVICE'S REMOVAL. THE LEAD ANCHOR WAS DISCARDED BY THE MEDICAL FACILITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SWIFT-LOCK ANCHOR | SPINAL CORD STIMULATION LEAD ANCHOR | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 1192 | 3269449 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |