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 2020-01-10 for CARELINK SMARTSYNC BASE 24970A manufactured by Plexus Manufacturing Sdn. Bhd.
[175689009]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[175689010]
It was reported that the user was unable to obtain right ventricular (rv) lead or right atrial (ra) lead impedance from the programmer when initially connected to the leads during implant. It was noted that the programmer would not provide an impedance measurement when the lead was connected to the alligator clips. The user noted that when changed to vvi or aai mode, whether pacing or not, the programmer would not give a measurement or update the impedance. The user noted that when they went to the threshold screen and then exited the screen, the impedance measurement would be taken or updated. The programmer remains in use. No patient complications have been reported as a result of this event.
Patient Sequence No: 1, Text Type: D, B5
[186213516]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
[188582975]
Product analysis:analysis confirmed that the impedance issue is related to a known formal investigation. Impedance value does not refresh after clicking the impedance button. The impedance measurement requires both atrial and ventricular events. Depending on the events mode, it could take a few seconds to show the measured value. If the user continues to tap the field faster than that, then the update will be delayed as every tap forces the device to take a new measurement. This issue has been resolved with a new software version. If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004593495-2020-00022 |
| MDR Report Key | 9577294 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-01-10 |
| Date of Report | 2020-02-07 |
| Date of Event | 2019-12-13 |
| Date Mfgr Received | 2020-02-04 |
| Device Manufacturer Date | 2018-12-07 |
| Date Added to Maude | 2020-01-10 |
| 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 | 2020-01-10 |
| 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 | 2020-01-10 |