MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2020-03-10 for VIVA CRT-P C6TR01 manufactured by Medtronic Europe Sarl.
[182772245]
Concomitant medical products: 511211 lead, implanted: (b)(6) 2014. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[182772246]
It was reported that the device reached elective replacement indicator due to possible premature battery depletion. The device was explanted and replaced. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[187305646]
Product event summary: the device was returned and analyzed. Returned product analysis was performed and no anomalies were found. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9614453-2020-00883 |
| MDR Report Key | 9812638 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2020-03-10 |
| Date of Report | 2020-03-27 |
| Date of Event | 2020-01-07 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2016-07-13 |
| Date Added to Maude | 2020-03-10 |
| 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 | 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 | VIVA CRT-P |
| Generic Name | PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION |
| Product Code | NKE |
| Date Received | 2020-03-10 |
| Returned To Mfg | 2020-02-14 |
| Model Number | C6TR01 |
| Catalog Number | C6TR01 |
| Device Expiration Date | 2017-12-28 |
| 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 | 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 | 2020-03-10 |