FDA Adverse Event
Injury
Summary report: N
INOGEN MINI ICD VR
MDR report key: 12660948
·
Received October 19, 2021
Report
- Report Number
- 2124215-2021-30142
- Event Type
- Injury
- Date Received
- October 19, 2021
- Date of Event
- September 21, 2021
- Report Date
- October 19, 2021
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- LWS
- UDI-DI
- 00802526533808
- PMA / PMN Number
- P960040/S306
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT THIS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REVERTED TO SAFETY CORE MODE UNEXPECTEDLY. TECHNICAL SERVICES (TS) DISCUSSED DEVICE FUNCTIONALITY AND RECOMMENDED DEVICE REPLACEMENT DUE TO LIMITED THERAPY AVAILABLE IN SAFETY MODE. SURGICAL INTERVENTION WAS UNDERTAKEN. THE ICD WAS EXPLANTED AND REPLACED WITH A NEW DEVICE. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED. THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. IF THE DEVICE IS RETURNED, THIS REPORT WILL BE UPDATED WITH PERTINENT INFORMATION, UPON COMPLETION OF PRODUCT ANALYSIS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1556914 | INOGEN MINI ICD VR | IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (NON-CRT) | LWS | BOSTON SCIENTIFIC CORPORATION | D011 | 437639 | 00802526533808 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Hospitalization| R |