MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2016-08-09 for LEGEND 8416 manufactured by Mdt Puerto Rico Operations Co, Med Rel.
[51727582]
Patient Sequence No: 1, Text Type: N, H10
[51727583]
It was reported that the implantable pulse generator (ipg) device was unable to establish telemetry; showed no pacing spikes, and had no magnet response. The device remains in use, but a replacement was scheduled. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[101417199]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2647346-2016-00019 |
| MDR Report Key | 5861497 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2016-08-09 |
| Date of Report | 2016-05-19 |
| Date of Event | 2016-05-19 |
| Date Mfgr Received | 2016-05-19 |
| Date Added to Maude | 2016-08-09 |
| 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 | MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | ANNE SCHILLING |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635052036 |
| Manufacturer G1 | MDT PUERTO RICO OPERATIONS CO, MED REL |
| Manufacturer Street | ROAD 909, KM. 0.4., BARRIO MAR |
| Manufacturer City | HUMACAO PR 00792 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00792 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LEGEND |
| Generic Name | PULSE-GENERATOR, SINGLE CHAMBER, SENSOR DRIVEN, IMPLANTABLE |
| Product Code | LWO |
| Date Received | 2016-08-09 |
| Model Number | 8416 |
| Catalog Number | 8416 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MDT PUERTO RICO OPERATIONS CO, MED REL |
| Manufacturer Address | ROAD 909, KM. 0.4., BARRIO MAR HUMACAO PR 00792 US 00792 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2016-08-09 |