MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-03-14 for SOLARA CRT-P MRI SURESCAN W1TR03 manufactured by Medtronic Puerto Rico Operations Co..
[187335733]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[187335734]
Additional information was received and reported the device was replaced at the same time as a changeout from an epicardial to a transvenous system and was unrelated to the battery voltage measurement.
Patient Sequence No: 1, Text Type: D, B5
[188226748]
Concomitant medical products: 310c31 tissue valve, implanted: (b)(6) 2019. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188226749]
It was reported that there was an incorrect battery voltage measurement on the cardiac resynchronization therapy pacemaker (crt-p). 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
[188944994]
Secondary review of the reported event determined that there is improbable risk to the patient associated with this issue. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188944995]
It was reported that there was an incorrect battery voltage measurement on the cardiac resynchronization therapy pacemaker (crt-p) which did not affect device performance. The device was explanted and replaced at the same time as a changeout from an epicardial system to a transvenous system and was unrelated to the battery voltage measurement. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3004209178-2020-05382 |
| MDR Report Key | 9832575 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2020-03-14 |
| Date of Report | 2020-04-02 |
| Date of Event | 2019-09-21 |
| Date Mfgr Received | 2020-03-26 |
| Device Manufacturer Date | 2019-02-11 |
| Date Added to Maude | 2020-03-14 |
| 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 PUERTO RICO OPERATIONS CO. |
| Manufacturer Street | ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK |
| Manufacturer City | JUNCOS PR 00777 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00777 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOLARA CRT-P MRI SURESCAN |
| Generic Name | PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION |
| Product Code | NKE |
| Date Received | 2020-03-14 |
| Model Number | W1TR03 |
| Catalog Number | W1TR03 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC PUERTO RICO OPERATIONS CO. |
| Manufacturer Address | ROAD 31, KM. 24, HM 4 CEIBA NORTE INDUSTRIAL PARK JUNCOS PR 00777 US 00777 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-14 |