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 2020-03-30 for ASSURITY MRI PM2272 manufactured by St. Jude Medical, Inc.(crm-sylmar).
[185700703]
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
[185700704]
Related manufacturer reference number: 2017865-2020-04429; 2017865-2020-04430. It was reported that the patient presented in the hospital with a pocket infection. There is no known allegation from a health professional that suggests the infection was related to the dual chamber pacemaker system. The physician explanted and replaced the pacemaker, right atrial lead, and right ventricular lead. The patient was in stable condition.
Patient Sequence No: 1, Text Type: D, B5
[188149547]
As received, a pacemaker was returned above normal elective replacement indicator. No anomalies were found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2017865-2020-04427 |
| MDR Report Key | 9901363 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-10 |
| Device Manufacturer Date | 2020-01-22 |
| 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-SYLMAR) |
| Manufacturer Street | 15900 VALLEY VIEW COURT |
| Manufacturer City | SYLMAR CA 91342 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91342 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ASSURITY MRI |
| Generic Name | IMPLANTABLE PACEMAKER PULSE GENERATOR |
| Product Code | LWP |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-03-17 |
| Model Number | PM2272 |
| Catalog Number | PM2272 |
| Lot Number | A000092346 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ST. JUDE MEDICAL, INC.(CRM-SYLMAR) |
| Manufacturer Address | 15900 VALLEY VIEW COURT SYLMAR CA 91342 US 91342 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other; 2. Required No Informationntervention | 2020-03-30 |