FDA Adverse Event
Malfunction
Summary report: N
ADAPTA
MDR report key: 11125297
·
Received January 6, 2021
Report
- Report Number
- 3004209178-2021-00247
- Event Type
- Malfunction
- Date Received
- January 6, 2021
- Date of Event
- December 15, 2020
- Report Date
- January 6, 2021
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NVZ
- UDI-DI
- 00613994222084
- PMA / PMN Number
- P980035
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
CONCOMITANT MEDICAL PRODUCTS: MCS-P3-26-AOA VALVE, IMPLANT DATE: (B)(6) 2014. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT EXPERIENCED BRADYCARDIA ON THE MONITOR, BELOW THE LOWER RATE LIMIT ON THE IMPLANTABLE PULSE GENERATOR (IPG), WHILE MANAGED VENTRICULAR PACING WAS PROGRAMMED ON. THE IPG REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 22311 | ADAPTA | PULSE GENERATOR, PERMANENT, IMPLANTABLE | NVZ | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | ADDRL1 | 00613994222084 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 85 YR |