FDA Adverse Event
Malfunction
Summary report: N
PROBE SPK1004 SURGEON CONTROLLED
MDR report key: 3117952
·
Received May 17, 2013
Report
- Report Number
- 1045254-2013-00389
- Event Type
- Malfunction
- Date Received
- May 17, 2013
- Date of Event
- April 4, 2013
- Report Date
- April 19, 2013
- Manufacturer
- MEDTRONIC XOMED, INC.
- Product Code
- ETN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
PROBE SPK1004 SURGEON CONTROLLED. MODEL # / CATALOG # - SPK1004.
Additional Manufacturer Narrative · 1
(B)(4)
Additional Manufacturer Narrative · 1
THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. CONCOMITANT DEVICE: MODULE OPM660. PATIENT (ID: (B)(6), LOT: 206145081, RETURNED (B)(4) 2013, MANUFACTURED SEPTEMBER 18, 2012, 510K: K061639) (B)(4). THE PROBE WAS NOT RETURNED AND THEREFORE, NO EVALUATION COULD BE PERFORMED. THE CONCOMITANT DEVICE, THE MODULE, WAS RETURNED FOR EVALUATION. NO FAULT WAS FOUND WITH THIS DEVICE. METHOD: NO TESTING METHODS PERFORMED. (B)(4).
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE STIM PROBE DOES NOT FUNCTION. THERE WAS NO REPORTED PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 219259 | PROBE SPK1004 SURGEON CONTROLLED | STIMULATOR, NERVE | ETN | MEDTRONIC XOMED, INC. | SPK1004 | NOT PROVIDED |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |