MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2002-04-26 for VOCARE BLADDER SYSTEM 1904 * manufactured by Neurocontrol Corp..
[16289699]
A patient was implanted with the vocare bladder system in 2002. The device reportedly operated properly once following implantation but did not operate properly in subsequent attempts at use. The implanting surgeon reported observing slight abdominal muscle contractions when attempting to operate the device, which may indicate an improper connection within the implanted device system. More recently, the patient's bladder pressures with the use of the device are reportedly sometimes good and sometimes not, which may further indicate an intermittent connection. A consulting physician has recommended troubleshooting methods to check the connection between the implantable receiver-stimulator (irs) and electrode. A follow-up report will be submitted when additional information is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530440-2002-00005 |
| MDR Report Key | 390912 |
| Report Source | 00 |
| Date Received | 2002-04-26 |
| Date of Report | 2002-03-27 |
| Date of Event | 2002-03-21 |
| Date Mfgr Received | 2002-03-27 |
| Device Manufacturer Date | 2000-06-01 |
| Date Added to Maude | 2002-05-02 |
| 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 | 2002-04-26 |
| Model Number | 1904 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Device Expiration Date | 2002-06-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 379959 |
| Manufacturer | NEUROCONTROL CORP. |
| Manufacturer Address | 8333 ROCKSIDE RD. VALLEY VIEW OH 441256104 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. Other | 2002-04-26 |