MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer report with the FDA on 2018-10-22 for COMMUNICATOR 6498 manufactured by External Manufacturer.
[124491320]
The product is expected to be returned for analysis. This report will be updated upon return and completion of analysis.
Patient Sequence No: 1, Text Type: N, H10
[124491321]
Boston scientific received information that the recent lightning storm took out the communicator. The cord goes into the back of the communicator was melted. No power going to the communicator. A boston scientific company representative opted to replace the communicator and a return label was sent. The communicator was deactivated. No adverse patient effects were reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2124215-2018-14054 |
| MDR Report Key | 7989424 |
| Report Source | CONSUMER |
| Date Received | 2018-10-22 |
| Date of Report | 2018-07-17 |
| Date of Event | 2018-07-17 |
| Date Mfgr Received | 2018-07-17 |
| Device Manufacturer Date | 2014-03-12 |
| Date Added to Maude | 2018-10-22 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | TIM DEGROOT |
| Manufacturer Street | 4100 HAMLINE AVE. N |
| Manufacturer City | ST. PAUL MN |
| Manufacturer Phone | 6515826168 |
| Manufacturer G1 | EXTERNAL MANUFACTURER |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | COMMUNICATOR |
| Generic Name | ACCESSORY |
| Product Code | OSR |
| Date Received | 2018-10-22 |
| Model Number | 6498 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | EXTERNAL MANUFACTURER |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 4469 | 2018-10-22 |