FDA Adverse Event
Injury
Summary report: N
UNK
MDR report key: 966312
·
Received December 17, 2007
Report
- Report Number
- 2182207-2007-04473
- Event Type
- Injury
- Date Received
- December 17, 2007
- Report Date
- October 23, 2007
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- GZB
- PMA / PMN Number
- P840001
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
SEE SCANNED PAGES.
Description of Event or Problem · 1
JOURNAL REFERENCE: SGUEGLIA, ET AL. "LONG-TERM FOLLOW-UP OF PATIENTS WITH CARDIAC SYNDROME X TREATED BY SPINAL CORD STIMULATION" HEART JOURNAL, 2007, 93, 5, 591-597. TO ASSESS THE LONG-TERM EFFECT OF SPINAL CORD STIMULATION IN PATIENTS WITH REFRACTORY CARDIAC SYNDROME X. A PROSPECTIVE, CONTROLLED, LONG-TERM FOLLOW-UP WAS PERFORMED ON 19 PATIENTS WITH CSX FOR A MEDIAN OF 36 MONTHS. ONE PATIENT HAD SKIN INFECTION AT THE LEVEL OF THE PUNCTURE FOR THE SCREENING ELECTRODE CATHETER INTO THE EPIDURAL SPACE. THE SYSTEM WAS REMOVED AND REPLACED AFTER CONTROLLING THE INFECTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNK | GZB | MEDTRONIC NEUROMODULATION | UNK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK YR | Hospitalization| R | NEUROSTIMULATOR MODEL UNK| EXTENSION MODEL UNK |