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 2020-03-31 for CAPSUREFIX NOVUS LEAD MRI SURESCAN 5076-52 manufactured by Mpri.
[186592412]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186592413]
It was reported a pocket revision was performed approximately three weeks post implant of the cardiac resynchronization therapy defibrillator (crt-d) system as the device site wound was not healing. Approximately three weeks after pocket revision, when the patient was seen in clinic, the site bandage was removed and the device was visible through a hole in the incision. The device system was explanted due to infection and the patient was treated with antibiotics. It was further reported that during interrogation of the device for extraction, the left ventricular (lv) lead was reported to have high thresholds. No further patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[186604841]
Product event summary: the full lead was returned and analyzed. No anomalies were found. The distal low voltage electrode of the lead was covered in blood. The distal low voltage electrode of the lead was covered in body tissue. Visual analysis of the lead indicated apparent explant damage. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2649622-2020-06700 |
| MDR Report Key | 9903746 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-16 |
| Date Mfgr Received | 2020-03-17 |
| Device Manufacturer Date | 2019-10-21 |
| Date Added to Maude | 2020-03-31 |
| 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 | MPRI |
| Manufacturer Street | ROAD 149 KM 56.3 |
| Manufacturer City | VILLALBA PR 00766 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 00766 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAPSUREFIX NOVUS LEAD MRI SURESCAN |
| Generic Name | ELECTRODE, PACEMAKER, PERMANENT |
| Product Code | DTB |
| Date Received | 2020-03-31 |
| Returned To Mfg | 2020-03-27 |
| Model Number | 5076-52 |
| Catalog Number | 5076-52 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MPRI |
| Manufacturer Address | ROAD 149 KM 56.3 VILLALBA PR 00766 US 00766 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2020-03-31 |