MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2015-02-10 for LEGEND 8417 manufactured by Mdt Puerto Rico Operations Co, Med Rel.
[5335725]
It was reported that the fell and broke their neck. It was believed that the patient had passed out, possibly due to pacing pause. High impedance was noted, and no telemetry or device output were noted. It was noted that the patient had been lost to follow-up and had not seen a physician for 15 years. The device was explanted and replaced, and the lead was capped and replaced. No further patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[12966382]
(b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2647346-2015-00007 |
| MDR Report Key | 4499153 |
| Report Source | 05,07 |
| Date Received | 2015-02-10 |
| Date of Report | 2014-11-10 |
| Date Mfgr Received | 2014-11-10 |
| Date Added to Maude | 2015-02-10 |
| 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 | 0 |
| Event Location | 0 |
| 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 | MEDTRONIC CARDIAC RHYTHM HEART FAILURE |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55112 |
| 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 | 2015-02-10 |
| Returned To Mfg | 2014-11-24 |
| Model Number | 8417 |
| Catalog Number | 8417 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| 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 | 696158 | 1. Hospitalization; 2. Life Threatening; 3. Required No Informationntervention | 2015-02-10 |