FDA Adverse Event
Injury
Summary report: N
UNKNOWN CARDIOSEAL IMPLANT
MDR report key: 379459
·
Received March 1, 2002
Report
- Report Number
- 1222632-2002-00003
- Event Type
- Injury
- Date Received
- March 1, 2002
- Date of Event
- January 29, 2002
- Report Date
- March 1, 2002
- Manufacturer
- NMT MEDICAL, INC.
- Product Code
- MLV
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
SURGICAL REMOVAL OF TRANSEPTAL OCCLUDER - THROMBUS ON LEFT SIDE OF THE DEVICE.
Description of Event or Problem · 1
PATIENT PRESENTED AT MEDICAL CENTER WITH CHEST PAIN. A TEE WAS DONE AND SHOWED EVIDENCE OF THROMBUS ON THE DEVICE. IMPLANTING PHYSICIAN DR. WAS CONTACTED BY MEDICAL IN REGARDS TO THE PT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN CARDIOSEAL IMPLANT | CARDIOSEAL | MLV | NMT MEDICAL, INC. | NI | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 44 YR | Other| R |