FDA Adverse Event
Malfunction
Summary report: N
VOCARE BLADDER SYSTEM IMPLANTABLE ELECTRODE
MDR report key: 295143
·
Received September 8, 2000
Report
- Report Number
- 1530440-2000-00006
- Event Type
- Malfunction
- Date Received
- September 8, 2000
- Report Date
- January 18, 2000
- Manufacturer
- FINETECH MEDICAL LTD.
- Product Code
- GZC
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PT WAS IMPLANTED WITH THE VOCARE BLADDER SYSTEM IN AUSTRALIA. REGIONAL REP REPORTED PT WAS UNABLE TO USE SYSTEM. IT WAS DETERMINED THAT ONE EXTRADURAL LEAD HAD MIGRATED OUT OF POSITION AND WAS STIMULATING THE LATISSUMUS DORSI. INITIAL REPORTS HAVE NOT DETERMINED WHETHER THE EXTRADURAL LEAD HAD MIGRATED BECAUSE THE ANCHOR BECAME DETACHED OR BECAUSE THE SUTURE BECAME UNTIED. THE ORIGINAL DEVICE WAS LEFT IMPLANTED IN THE PT. THE PT HAD ELECTTIVE SURGERY TO IMPLANT A SECOND DEVICE IN 2000. NO REPORT OF ANY PT INJURY ASSOCIATED WITH EVENT AND/OR DEVICE. THE DEVICE REPLACEMNT HAS RESTORED FUNCTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | VOCARE BLADDER SYSTEM IMPLANTABLE ELECTRODE | IMPLANTABLE ELECTRODE | GZC | FINETECH MEDICAL LTD. | UNK | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Other |