FDA Adverse Event
Injury
Summary report: N
ANGSTROM II V-180 SERIES TIERED THERAPY
MDR report key: 317336
·
Received February 21, 2001
Report
- Report Number
- 2938836-2001-00025
- Event Type
- Injury
- Date Received
- February 21, 2001
- Date of Event
- January 9, 2001
- Report Date
- January 9, 2001
- Manufacturer
- ST. JUDE MEDICAL, INC., CRMD
- Product Code
- LWS
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ME, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
ST. JUDE MEDICAL LEARNED ON 01/22/2001 THAT THE DEVICE HAD BEEN EXPLANTED IN 2001 DUE TO PREMATURE BATTERY DEPLETION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 6675 | ANGSTROM II V-180 SERIES TIERED THERAPY | IMPLANTABLE CARDIAC DEFIBRILLATOR | LWS | ST. JUDE MEDICAL, INC., CRMD | V-180HV3 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Other | SP01, THERAPY DATES: NA. |