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.
[186667235]
Concomitant medical products: dtmb1d1 crt-d, implanted: (b)(6) 2018. . If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[186667236]
It was reported that the right ventricular (rv) lead exhibited oversensing and noise which caused pauses. The patient was lightheaded as a result the lead was explanted and replaced. No further patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[186858679]
Product analysis summary: the partial lead was returned in segments, analyzed. Analysis indicated the proximal conductor of the lead developed a fracture due to flexing while in vivo. The interior superior vena cava defibrillation cable developed a fracture due to flexing while in vivo. The right ventricular defibrillation coil developed a fracture due to flexing while in vivo. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2649622-2020-06696 |
| MDR Report Key | 9903629 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-11 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2006-07-14 |
| 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 |
| Returned To Mfg | 2020-03-16 |
| Model Number | 694965 |
| Catalog Number | 694965 |
| Device Expiration Date | 2008-07-11 |
| Operator | LAY USER/PATIENT |
| Device Availability | R |
| 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 |