MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-30 for REVEAL LINQ LNQ11 manufactured by Medtronic Europe Sarl.
[185508292]
Product event summary: the device was returned and analyzed. The returned device had a broken crystal. Hybrid analysis confirmed the no-telemetry condition. The cause of the no-telemetry was a defective crystal oscillator which is used to generate the telemetry clock. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[185508293]
It was reported that the implantable cardiac monitor (icm) patient died as a result of a gunshot wound to the chest. The device explanted and returned for analysis. Analysis of the device was performed and the device tested out of specification. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9614453-2020-01105 |
| MDR Report Key | 9897262 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2019-10-24 |
| Date Mfgr Received | 2020-03-19 |
| Device Manufacturer Date | 2018-09-06 |
| Date Added to Maude | 2020-03-30 |
| 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 | PAULA BIXBY |
| Manufacturer Street | 8200 CORAL SEA ST NE |
| Manufacturer City | MOUNDS VIEW MN 55112 |
| Manufacturer Country | US |
| Manufacturer Postal | 55112 |
| Manufacturer Phone | 7635055378 |
| Manufacturer G1 | MEDTRONIC EUROPE SARL |
| Manufacturer Street | ROUTE DU MOLLIAU 31 CASE POSTALE |
| Manufacturer City | TOLOCHENAZ VAUD 1131 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 1131 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | REVEAL LINQ |
| Generic Name | DETECTOR AND ALARM, ARRHYTHMIA |
| Product Code | DSI |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2019-11-14 |
| Model Number | LNQ11 |
| Catalog Number | LNQ11 |
| Device Expiration Date | 2019-08-28 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC EUROPE SARL |
| Manufacturer Address | ROUTE DU MOLLIAU 31 CASE POSTALE TOLOCHENAZ VAUD 1131 CH 1131 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |