FDA Adverse Event
Injury
Summary report: N
CINCH LEAD ANCHOR
MDR report key: 1940480
·
Received December 21, 2010
Report
- Report Number
- 1627487-2010-03829
- Event Type
- Injury
- Date Received
- December 21, 2010
- Date of Event
- March 15, 2010
- Report Date
- June 23, 2010
- Manufacturer
- ST JUDE MEDICAL - NEUROMODULATION DIVISION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
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 4 OF 4. SEE MFR REPORT #S 1627487-2010-03826, 1627487-2010-03827 AND 1627487-2010-03828. THE PT RECEIVED HIS SCS SYSTEM CONSISTING OF AN IPG, TWO PERCUTANEOUS LEADS AND TWO ANCHORS. IT WAS REPORTED THAT THE PT WAS RECEIVING PAINFUL STIMULATION. CONSEQUENTLY, THE PHYSICIAN REMOVED HIS SCS SYSTEM ON (B)(6) 2010. THE EXPLANTED DEVICES WERE RETURNED TO THE MFR FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CINCH LEAD ANCHOR | SPINAL CORD STIMULATION ACCESSORY | LGW | ST JUDE MEDICAL - NEUROMODULATION DIVISION | 1194 | 119791 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |