FDA Adverse Event
Death
Summary report: N
INTERVENE LEAD
MDR report key: 383408
·
Received February 8, 2002
Report
- Report Number
- 2124215-2002-03688
- Event Type
- Death
- Date Received
- February 8, 2002
- Date of Event
- October 5, 2001
- Report Date
- October 11, 2001
- Manufacturer
- CARDIAC PACEMAKERS
- Product Code
- LWS
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION GUIDANT RECEIVED INFORMATION THAT THE PATIENT WAS HOSPITALIZED FOR PNEUMONIA, DURING WHICH, HE SUFFERED A CARDIAC ARREST. THE PATIENT LATER GOES INTO EMD AND DIES. THE PHYSICIAN SUSPECTS THAT THE ICD DETECTED THE PATIENT'S VF BUT DID NOT ADEQUATELY TREAT IT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTERVENE LEAD | IMPLANTABLE LEAD | LWS | CARDIAC PACEMAKERS | 497-19 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Death | THE DEVICE 438-/08688M WAS IMPLANTED 06-AUG-1998| THE DEVICE 101-/01523 WAS IMPLANTED 06-AUG-1998 |