MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2020-03-30 for FORTIFY DR, U1.6 SJ4 US CD2231-40Q manufactured by St. Jude Medical, Inc.(crm-sunnyvale).
[185716424]
The device is included in the battery performance alert advisory issued by abbott on 28 august 2017. Di not available as product was manufactured on or before september 23, 2014. The results of the investigation are inconclusive since the device was not returned for analysis. Based on the information received, the cause of the reported incident could not be conclusively determined.
Patient Sequence No: 1, Text Type: N, H10
[185716425]
Following the battery performance alert (bpa) advisory, a bpa was received by the clinician and the device was explanted.
Patient Sequence No: 1, Text Type: D, B5
[188152508]
New information received indicates that the generator replacement was uneventful and completed without any complication. The patient was discharged in his baseline state of health.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2938836-2020-02322 |
| MDR Report Key | 9901560 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-07 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2011-11-16 |
| Date Added to Maude | 2020-03-30 |
| 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 | ELIZABETH BOLTZ |
| Manufacturer Street | 15900 VALLEY VIEW COURT |
| Manufacturer City | SYLMAR CA 91342 |
| Manufacturer Country | US |
| Manufacturer Postal | 91342 |
| Manufacturer G1 | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) |
| Manufacturer Street | 645 ALMANOR AVENUE |
| Manufacturer City | SUNNYVALE CA 94085 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 94085 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Removal Correction Number | Z-0003-2018 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FORTIFY DR, U1.6 SJ4 US |
| Generic Name | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR |
| Product Code | NVZ |
| Date Received | 2020-03-30 |
| Model Number | CD2231-40Q |
| Lot Number | 3553829 |
| Device Expiration Date | 2013-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) |
| Manufacturer Address | 645 ALMANOR AVENUE SUNNYVALE CA 94085 US 94085 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2020-03-30 |