MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-12-11 for CARELINK SMARTSYNC BASE 24970A manufactured by Plexus Manufacturing Sdn. Bhd.
[170235725]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[170235726]
It was reported that during a normal device change out, the patient experienced 5-10 seconds of bradycardia with a low escape rhythm of 10 beats per minute. The physician placed the programmer cables on the lead and it was noticed that there was no capture from the programmer. The physician quickly attached the leads to the new device and all was noted to be ok. When trying to determine what the issues was, it was noted that the tablet screen appeared normal except for no ventricular pacing output display. The output on the programmer was attempted to be changed to something else and the screen changed but errors were displayed. The programmer remains in use. No further patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[188583386]
Analysis of the logs was unable to confirm that the user connected to the analyzer on the date specified but the logs indicated that the analyzer was connected to on the previous day. The logs showed that there was poor signal strength during the time of use which was an issue that was had been previously documented for further investigation. Logs also showed that the user was switching the application background/foreground which cause a safety ping timeout as designed. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004593495-2019-01285 |
| MDR Report Key | 9450383 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2019-12-11 |
| Date of Report | 2020-03-24 |
| Date of Event | 2019-12-03 |
| Date Mfgr Received | 2020-02-26 |
| Device Manufacturer Date | 2018-08-23 |
| Date Added to Maude | 2019-12-11 |
| 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 | PLEXUS MANUFACTURING SDN. BHD |
| Manufacturer Street | BAYAN LEPAS FREE INDUSTRIAL ZO |
| Manufacturer City | BAYAN LEPAS 11900 |
| Manufacturer Country | MY |
| Manufacturer Postal Code | 11900 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARELINK SMARTSYNC BASE |
| Generic Name | ANALYZER, PACEMAKER GENERATOR FUNCTION |
| Product Code | DTC |
| Date Received | 2019-12-11 |
| Model Number | 24970A |
| Catalog Number | 24970A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PLEXUS MANUFACTURING SDN. BHD |
| Manufacturer Address | BAYAN LEPAS FREE INDUSTRIAL ZO BAYAN LEPAS 11900 MY 11900 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2019-12-11 |