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 SPRINT FIDELIS 694965 manufactured by Mpri.
[186097704]
Concomitant medical products: dtba1d1, implanted: (b)(6) 2014. 5071 x2 leads, implanted: (b)(6) 2007. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186097705]
It was reported that the right ventricular (rv) lead had high pacing impedance. Initially, programming changes were made and subsequently, the lead was explanted and replaced. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2649622-2020-06704 |
| MDR Report Key | 9904333 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-10 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2006-08-23 |
| 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 | SPRINT FIDELIS |
| Generic Name | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER |
| Product Code | LWS |
| Date Received | 2020-03-31 |
| Model Number | 694965 |
| Catalog Number | 694965 |
| Device Expiration Date | 2008-08-16 |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| 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 |