MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-03 for PERCEPTA CRT-P MRI SURESCAN W1TR01 manufactured by Medtronic Puerto Rico Operations Co..
[183389666]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183389667]
It was reported that during the implant procedure, the right ventricular (rv) lead exhibited? High, undefined impedances, no sensing, and no pacing. It was determined that the set screw of the cardiac resynchronization therapy pacemaker (crt-p) was the cause of the rv lead issues. The physician tried to loosen the set screw due to the issues observed and the set screw dislodged. The physician could not reinsert the set screw back into the device header so 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
[188491688]
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 | 3004209178-2020-04558 |
| MDR Report Key | 9782870 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-03 |
| Date of Report | 2020-03-17 |
| Date of Event | 2020-02-06 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2019-12-17 |
| Date Added to Maude | 2020-03-03 |
| 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 | PERCEPTA CRT-P MRI SURESCAN |
| Generic Name | PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION |
| Product Code | NKE |
| Date Received | 2020-03-03 |
| Returned To Mfg | 2020-02-25 |
| Model Number | W1TR01 |
| Catalog Number | W1TR01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2020-03-03 |