MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2001-06-14 for VOCARE BLADDER SYSTEM 1452-1 NA manufactured by Neurocontrol Corp..
[227764]
Product malfunction: the vocare surgical stimulator was used intraoperatively for recurrent laryngeal nerve stimulation under an investigtional protocol. During the procedure, the vocare surgical stimulator was activated but did not produce the expected neurological response. A standard ent surgical stimulator was used to complete the procedure, and there was no adverse effect on the pt. The vocare surgical stimulator is intended to be used to stimulate and identify spinal nerve roots during the rhizotomy and electrode placement procedures as part of the vocare bladder system implant surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530440-2001-00019 |
| MDR Report Key | 337882 |
| Report Source | 05,07 |
| Date Received | 2001-06-14 |
| Date of Report | 2001-03-15 |
| Date of Event | 2001-03-14 |
| Date Mfgr Received | 2001-03-15 |
| Date Added to Maude | 2001-06-20 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | MICHAEL SOUTHWORTH |
| Manufacturer Street | 8333 ROCKSIDE ROAD |
| Manufacturer City | VALLEY VIEW OH 44125 |
| Manufacturer Country | US |
| Manufacturer Postal | 44125 |
| Manufacturer Phone | 2169120101 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VOCARE BLADDER SYSTEM |
| Generic Name | SURGICAL STIMULATOR |
| Product Code | GZC |
| Date Received | 2001-06-14 |
| Returned To Mfg | 2001-03-16 |
| Model Number | 1452-1 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 327186 |
| Manufacturer | NEUROCONTROL CORP. |
| Manufacturer Address | 8333 ROCKSIDE RD. VALLEY VIEW OH 44125 US |
| Baseline Brand Name | VOCARE BLADDER SYSTEM |
| Baseline Generic Name | SURGICAL STIMULATOR |
| Baseline Model No | 1452-1 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | VOCARE BLADDER SYSTEM SURGICAL STIMULATOR |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | Y |
| Premarket Approval | H9800 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-06-14 |