FDA Adverse Event
Injury
Summary report: N
QUATTRODE
MDR report key: 2792226
·
Received October 10, 2012
Report
- Report Number
- 1627487-2012-10566
- Event Type
- Injury
- Date Received
- October 10, 2012
- Date of Event
- September 19, 2012
- Report Date
- September 19, 2012
- Manufacturer
- ST. JUDE MEDICAL - NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P010032
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.
Description of Event or Problem · 1
DEVICE 2 OF 3. REFERENCE MFR REPORT: 1627487-2012-10565, 1627487-2012-10567. IT WAS REPORTED, THE PATIENT HAS AN OCCIPITAL NERVE STIMULATOR SYSTEM. DIAGNOSTIC TESTING IDENTIFIED INVALID IMPEDANCES. THE LEAD EXTENSION AND TWO LEADS WERE REMOVED AND REPLACED. EFFECTIVE STIMULATION WAS ACHIEVED POST-OPERATIVELY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | QUATTRODE | SCS LEAD | LGW | ST. JUDE MEDICAL - NEUROMODULATION | 3143 | 2844850 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention | SCS IPG: MODEL 3608 |