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 2019-11-27 for ALLURE QUADRA RF CRT-P PM3242 manufactured by St. Jude Medical, Inc.(crm-sunnyvale).
[168435211]
The results/method and conclusion codes along with investigation results will be provided in the final report.
Patient Sequence No: 1, Text Type: N, H10
[168435212]
It was reported that upon interrogation, the device was found to be at end of service (eos). When the pacemaker-dependent patient presented for a generator change, eos was confirmed. Based on the last remote transmission in (b)(6) 2018, this suggested premature battery depletion. The device was explanted and replaced without complication. The patient was stable.
Patient Sequence No: 1, Text Type: D, B5
[183403295]
The reported field event of longevity anomalies and early battery depletion was not confirmed in the laboratory. The device was tested on the bench and no anomalies were found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2938836-2019-16736 |
| MDR Report Key | 9387334 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-11-27 |
| Date of Report | 2019-11-27 |
| Date of Event | 2019-11-08 |
| Date Mfgr Received | 2019-11-08 |
| Device Manufacturer Date | 2015-07-15 |
| Date Added to Maude | 2019-11-27 |
| 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 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALLURE QUADRA RF CRT-P |
| Generic Name | IMPLANTABLE PACEMAKER PULSE GENERATOR |
| Product Code | NIK |
| Date Received | 2019-11-27 |
| Model Number | PM3242 |
| Lot Number | A000009091 |
| Device Expiration Date | 2017-01-31 |
| 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 | 2019-11-27 |