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 2020-03-17 for SERENA CRT-P MRI SURESCAN W1TR02 manufactured by Medtronic Puerto Rico Operations Co..
[183749269]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[183749270]
It was reported that the right atrial (ra) lead pacing threshold had been rising for approximately one year and the pacing impedance had been increasing for more than one year. The ra lead was then checked a few months later and it was noted the pacing impedance was then high/undefined in both unipolar and bipolar configuration. The patient was referred for a lead replacement and a ra lead fracture was suspected. During the revision procedure, the physician capped the ra lead and replaced with a new lead. While attempting to connect the new ra lead to the cardiac resynchronization therapy pacemaker (crt-p), the physician could no longer get the wrench to engage the setscrew of the device. The physician noted the wrench seemed to go through the grommet as expected, however, the wrench would not seat on the setscrew. The wrench was tried on the ventricular lead and no anomalies were observed. A second wrench was used to engage the atrial setscrew to no avail. The physician elected to replace the crt-p, as they did not believe there was an issue with wrench. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[187336011]
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 | 3004209178-2020-05541 |
| MDR Report Key | 9842883 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-17 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-10-01 |
| Date Mfgr Received | 2020-03-24 |
| Device Manufacturer Date | 2019-02-21 |
| Date Added to Maude | 2020-03-17 |
| 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 | SERENA CRT-P MRI SURESCAN |
| Generic Name | PULSE GENERATOR, PACEMAKER, IMPLANTABLE, WITH CARDIAC RESYNCHRONIZATION |
| Product Code | NKE |
| Date Received | 2020-03-17 |
| Returned To Mfg | 2020-03-05 |
| Model Number | W1TR02 |
| Catalog Number | W1TR02 |
| 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 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 | 5076 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-17 |