MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-04-06 for VOCARE BLADDER SYSTEM 1904 NA manufactured by Neurocontrol Corporation.
[272660]
A pt was implant with the vocare bladder system in 2002. This pt experienced occasional post-operative swelling over the site of the implantable receiver-stimulator (irs). After discharge from the hospital pt reported a slight opening of the skin edges of the surgical wound at the site of the rhizotomy associated with the device implant surgery and was instructed by a clinician to scrub the area of the open wound. The pt returned 4 weeks later with an elevated temperature and increased swelling over the implant. Aspiration of this swelling produced pus which was sent for culture and found to contain staphyloccocus aureus. Pt was placed on intravenous vancomycin and pt's temperature returned to normal. Three days later the irs was explanted, dividing its cables in the midline at the back to leave the electrodes in place. The pt was placed on a six-week course of intravenous vancomycin and was discharged from the hospital the next day and will be followed up as an outpatient by the hospital.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530440-2002-00004 |
| MDR Report Key | 386397 |
| Report Source | 05 |
| Date Received | 2002-04-06 |
| Date of Report | 2002-03-07 |
| Date of Event | 2002-03-04 |
| Date Mfgr Received | 2002-03-07 |
| Device Manufacturer Date | 2000-03-01 |
| Date Added to Maude | 2002-04-09 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VOCARE BLADDER SYSTEM |
| Generic Name | SACRAL ANTERIOR ROOT STIMULATOR FOR BLADDER/BOWEL |
| Product Code | GZC |
| Date Received | 2002-04-06 |
| Model Number | 1904 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Device Expiration Date | 2002-03-31 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 375431 |
| Manufacturer | NEUROCONTROL CORPORATION |
| Manufacturer Address | 8333 ROCKSIDE ROAD VALLEY VIEW OH 44125 US |
| Baseline Brand Name | VOCARE BLADDER SYSTEM |
| Baseline Generic Name | SACRAL ANTERIOR ROOT STIMULATOR FOR BLADDER/BOWEL |
| Baseline Model No | 1904 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-04-06 |