FDA Adverse Event
Malfunction
Summary report: N
STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE
MDR report key: 3122921
·
Received May 21, 2013
Report
- Report Number
- 3007566237-2013-01697
- Event Type
- Malfunction
- Date Received
- May 21, 2013
- Date of Event
- April 19, 2013
- Report Date
- April 19, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- EZW
- PMA / PMN Number
- P970004
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
CONCOMITANT PRODUCTS: PRODUCT ID 3889-28, LOT# VA07HNZ, IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE CASE TOOK PLACE ON (B)(6) 2013.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHEN THEY TESTED THE STIMULATION DURING THE LEAD IMPLANT PROCEDURE, THE PATIENT WAS NOT FEELING ANY STIMULATION WITH THE LEAD. IT WAS NOTED THAT THEY MOVED UP AND DOWN THE LEAD AND THE PATIENT CONTINUED TO RECEIVE NO COVERAGE. PRIOR TO LEAD INSERTION, THE PATIENT WAS GETTING GREAT STIMULATION WHEN NEEDLE TESTED. THE SAME TEST STIMULATION BOX WAS USED TWO SECONDS PRIOR AND WAS WORKING FINE. THE LEAD WAS REPLACED AND THE NEW LEAD WORKED FINE. THE OLD LEAD WAS THROWN INTO THE SHARP CONTAINER AND COULD NOT BE RETRIEVED BACK FOR ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 224081 | STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE | EZW | MEDTRONIC NEUROMODULATION | NEU_ENS_STIMULATOR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00040 YR |