FDA Adverse Event
Malfunction
Summary report: N
IPERIA 7 DR-T DF-1 PROMRI
MDR report key: 13765101
·
Received March 15, 2022
Report
- Report Number
- 1028232-2022-01286
- Event Type
- Malfunction
- Date Received
- March 15, 2022
- Date of Event
- December 25, 2021
- Report Date
- April 14, 2026
- Manufacturer
- BIOTRONIK SE & CO. KG
- Product Code
- MRM
- UDI-DI
- 04035479128777
- PMA / PMN Number
- P050023
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
PATIENT RECEIVED MULTIPLE INAPPROPRIATE SHOCKS. DEVICE WENT EOS DECEMBER 25, 2021, POSSIBLY RELATED TO OVER 50 SHOCKS. BATTERY LONGEVITY PRIOR TO SHOCKS WAS 60 PERCENT. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS FILE WILL BE UPDATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 822934 | IPERIA 7 DR-T DF-1 PROMRI | ICD | MRM | BIOTRONIK SE & CO. KG | 392409 | 04035479128777 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |