MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01 report with the FDA on 2004-05-14 for FREEHAND SYSTEM 1060-1 * manufactured by Neurocontrol Corp..
[383242]
The user was implanted with the freehand system 1996. Pt has been a regular user of the system. Earlier this year pt reported that the grasp strength varied, tightening and loosening rapidly. At a further assessment, it appeared that individual channel were swapping between muscles. This fault is consistent with a failure related to moisture trapped inside the implantable receiver-stimulator (irs) capsule, a problem that was the subject a previous recall.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530440-2004-00003 |
| MDR Report Key | 561176 |
| Report Source | 00,01 |
| Date Received | 2004-05-14 |
| Date of Report | 2004-05-14 |
| Date Mfgr Received | 2004-04-13 |
| Device Manufacturer Date | 1996-05-01 |
| Date Added to Maude | 2004-12-27 |
| 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 | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DARYN KINKOPH |
| Manufacturer Street | 8333 ROCKSIDE ROAD |
| Manufacturer City | VALLEY VIEW OH 44125 |
| Manufacturer Country | US |
| Manufacturer Postal | 44125 |
| Manufacturer Phone | 2169120101 |
| Manufacturer G1 | NEUROCONTROL CORPORATION |
| Manufacturer Street | 8333 ROCKSIDE ROAD |
| Manufacturer City | VALLEY VIEW OH 44125 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 44125 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | 9028925-11/07/00-003 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FREEHAND SYSTEM |
| Generic Name | HAND GRASP NEUROPROSTHESIS |
| Product Code | GZC |
| Date Received | 2004-05-14 |
| Returned To Mfg | 2005-09-22 |
| Model Number | 1060-1 |
| Catalog Number | * |
| Lot Number | * |
| ID Number | * |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | V |
| Device Sequence No | 1 |
| Device Event Key | 550882 |
| Manufacturer | NEUROCONTROL CORP. |
| Manufacturer Address | 8333 ROCKSIDE ROAD VALLEYVIEW OH 44125 US |
| Baseline Brand Name | FREEHAND SYSTEM |
| Baseline Generic Name | NEUROMUSCULAR STIMULATOR IMPLANT |
| Baseline Model No | 1060-1 |
| 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. Hospitalization; 2. Required No Informationntervention | 2004-05-14 |