MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-30 for MERLIN PROGRAMMER 3650 manufactured by Abbott.
[185686357]
Further information was requested but not received. 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
[185686358]
Related manufacturer reference number: 2017865-2020-04258. During an in clinic follow-up, the device was interrogated by the programmer. It was reported that the programmer was freezing, which changed device settings and the device went into backup operations. The patient experience discomfort due to the emergency pacing setting. A replacement programmer was used to reprogram the device to resolve the event. The patient was stable with no consequences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2017865-2020-03927 |
| MDR Report Key | 9900723 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-04 |
| Date Mfgr Received | 2020-03-15 |
| Device Manufacturer Date | 2006-08-10 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | ABBOTT |
| 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 | MERLIN PROGRAMMER |
| Generic Name | PROGRAMMER, PACEMAKER |
| Product Code | NIK |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-03-25 |
| Model Number | 3650 |
| Catalog Number | 3650 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT |
| Manufacturer Address | 15900 VALLEY VIEW COURT SYLMAR CA 91342 US 91342 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-30 |