MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2002-02-28 for FREEHAND SYSTEM 1060-2 NA manufactured by Neurocontrol Corp..
[253943]
This pt was implanted with the freehand system hand grasp neuroprosthesis in 2001. In 2001 drainage was observed on the pt's clothing through an opening in the skin on the upper-middle arm. The pt was treated by a physician and released. Ten days later the pt was seen by a surgeon who evaluated the pt and treated with antibiotics. Approx one week later, the pt was seen again by the surgeon, who has cultures taken, determined the pt to be mrsa-positive, and further treated with antibiotics. Approx one additional week later, the surgeon explanted the implantable receiver-stimulator (irs) and electrode connectors. During the explant surgery an electrode lead was found to be kinked near the connector site, which appeared to be the source of the skin erosion. The surgeon did not explant the electrodes at that time as the infection appeared not to have spread to the electrodes and the surgeon wanted to avoid the invasive procedure required for electrode explantation if possible. Antibiotic therapy was continued. However, in 2002 the pt was seen again by the surgeon, who determined that the antibiotic therapy was ineffective and explanted the electrodes. The antibiotic therapy was continued following electrode explantation and the infection has since resolved.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530440-2002-00001 |
| MDR Report Key | 380189 |
| Report Source | 05 |
| Date Received | 2002-02-28 |
| Date of Report | 2002-02-28 |
| Date of Event | 2001-12-01 |
| Date Mfgr Received | 2002-01-30 |
| Device Manufacturer Date | 2001-06-01 |
| Date Added to Maude | 2002-03-08 |
| 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 | FREEHAND SYSTEM |
| Generic Name | HAND GRASP NEUROPROSTHESIS |
| Product Code | GZC |
| Date Received | 2002-02-28 |
| Model Number | 1060-2 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Device Expiration Date | 2003-06-01 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | M |
| Device Sequence No | 1 |
| Device Event Key | 369235 |
| Manufacturer | NEUROCONTROL CORP. |
| Manufacturer Address | 8333 ROCKSIDE RD. VALLEY VIEW OH 44125 US |
| Baseline Brand Name | FREEHHAND SYSTEM |
| Baseline Generic Name | NEUROMUSCULAR STIMULATOR IMPLANT |
| Baseline Model No | 1060-2 |
| Baseline Catalog No | NA |
| Baseline ID | NA |
| Baseline Device Family | FREEHAND SYSTEM IMPLANTABLE RECEIVER STIMULATOR |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | Y |
| Premarket Approval | P9500 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2002-02-28 |