MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,07 report with the FDA on 2001-05-09 for FREEHAND SYSTEM 1060-2 NA manufactured by Neurocontrol Corp..
[17108487]
During initial programming of a freehand system for a recently implanted pt, it was reported difficult to achieve stable coupling between the external transmit coil and the implantable receiver stimulator (irs). Coupling varied depending upon the device user's position (i. E. , lying down vs. Sitting up). It is believed that the irs was implanted too deeply within the user's chest. A revision surgery to reposition the irs may be required to achieve stable coupling and system operation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1530440-2001-00015 |
| MDR Report Key | 331730 |
| Report Source | 04,07 |
| Date Received | 2001-05-09 |
| Date of Report | 2001-04-09 |
| Date of Event | 2001-04-09 |
| Date Mfgr Received | 2001-04-09 |
| Device Manufacturer Date | 2001-02-01 |
| Date Added to Maude | 2001-05-14 |
| 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 | PAMELA THOMAS |
| 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 | FREEHAND SYSTEM |
| Generic Name | IMPLANTABLE RECEIVER STIMULATOR |
| Product Code | GZC |
| Date Received | 2001-05-09 |
| Model Number | 1060-2 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Device Expiration Date | 2003-02-01 |
| 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 | 321099 |
| 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. Other | 2001-05-09 |