MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-24 for STRYKER JOSEPHSON HEXAPOLAR CATHETER RM5010528 manufactured by Stryker Sustainability Solutions Phoenix.
[124823215]
The stryker josephson fixed hexapolar catheter showed no electrograms when properly plugged in and placed in the heart. Removed from service, new catheter used. No patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7998687 |
| MDR Report Key | 7998687 |
| Date Received | 2018-10-24 |
| Date of Report | 2018-10-19 |
| Date of Event | 2018-10-02 |
| Report Date | 2018-10-19 |
| Date Reported to FDA | 2018-10-19 |
| Date Reported to Mfgr | 2018-10-24 |
| Date Added to Maude | 2018-10-24 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STRYKER JOSEPHSON HEXAPOLAR CATHETER |
| Generic Name | CATHETER, RECORDING, ELECTRODE, REPROCESSED |
| Product Code | NLH |
| Date Received | 2018-10-24 |
| Model Number | RM5010528 |
| Lot Number | 12442 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER SUSTAINABILITY SOLUTIONS PHOENIX |
| Manufacturer Address | 10232 S. 51ST ST. PHOENIX AZ 85044 US 85044 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-24 |