MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07,company representative, report with the FDA on 2014-04-10 for LEGEND II 8424 manufactured by Mdt Puerto Rico Operations Co, Med Rel.
[4309097]
It was reported that the patient came to the emergency room where it was noted that the device was completely dead and no telemetry could be established. The device was explanted and replaced. During the replacement procedure, it was noted that there was low impedance and high threshold, and fluoroscopy showed that the lead had dislodged. The lead was capped and replaced. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[11791341]
The information submitted reflects all relevant data received. If additional relevant information is received, a supplemental report will be submitted. Products: (b)(4) implantable tissue valve, (b)(6) 1996. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[12164630]
Evaluation summary: analysis of the device revealed normal battery depletion.
Patient Sequence No: 1, Text Type: N, H10
[101414384]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2647346-2014-00022 |
| MDR Report Key | 3740968 |
| Report Source | 05,07,COMPANY REPRESENTATIVE, |
| Date Received | 2014-04-10 |
| Date of Report | 2014-01-24 |
| Date Mfgr Received | 2014-04-21 |
| Date Added to Maude | 2014-04-11 |
| 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 | NASHOANE FULWOOD-KELLEY |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635260583 |
| Manufacturer G1 | MEDTRONIC CARDIAC RHYTHM DISEASE MGMT |
| 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 II |
| Generic Name | PULSE-GENERATOR, SINGLE CHAMBER, SENSOR DRIVEN, IMPLANTABLE |
| Product Code | LWO |
| Date Received | 2014-04-10 |
| Returned To Mfg | 2014-02-21 |
| Model Number | 8424 |
| Catalog Number | 8424 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Age | DA |
| 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 | 4024 | 1. Hospitalization; 2. Required No Informationntervention | 2014-04-10 |