MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-11-29 for ENSURA DR MRI SURESCAN EN1DR01 manufactured by Medtronic Europe Sarl.
[168443363]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[168443364]
It was reported that high thresholds was noted on the right ventricular (rv) lead. As a result the implantable pulse generator (ipg) experienced premature battery depletion. The lead and ipg were explanted and replaced. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[187305550]
Product event summary:the device was returned and analyzed. The device met 86. 4% of expected longevity. Without the history of the programmed settings throughout its service life, there is no way to determine why the longevity did not match the predicted model. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
Report Number | 9614453-2019-03999 |
MDR Report Key | 9391777 |
Report Source | COMPANY REPRESENTATIVE,FOREIG |
Date Received | 2019-11-29 |
Date of Report | 2019-11-29 |
Date of Event | 2019-11-06 |
Date Mfgr Received | 2019-11-06 |
Device Manufacturer Date | 2016-04-21 |
Date Added to Maude | 2019-11-29 |
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 | ENSURA DR MRI SURESCAN |
Generic Name | PULSE GENERATOR, PERMANENT, IMPLANTABLE |
Product Code | NVZ |
Date Received | 2019-11-29 |
Model Number | EN1DR01 |
Catalog Number | EN1DR01 |
Device Expiration Date | 2017-10-14 |
Operator | LAY USER/PATIENT |
Device Availability | N |
Device Eval'ed by Mfgr | * |
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 | 5076 | 1. Hospitalization; 2. Required No Informationntervention | 2019-11-29 |