FDA Adverse Event
Summary report: N
CARDIAC PACEMAKERS, INC.
MDR report key: 132452
·
Received November 11, 1997
Report
- Report Number
- 132452
- Date Received
- November 11, 1997
- Report Date
- October 29, 1997
- Manufacturer
- CARDIAC PACEMAKERS, INC.
- Product Code
- LWS
- Report Source
- User Facility report
- Reporter Location
- IL, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PT HAD AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR GENERATOR CHANGE 10/17/97 (THE ICD WAS ORIGINALLY IMPLANTED 10/5/93-A LEAD AND A SQ PATCH WERE ALSO IMPLANTED IN 1993). FOLLOWING SURGERY A LARGE HEMATOMA DEVELOPED AND THERE WAS BLEEDING FROM THE INCISION. A HEMATOMA EVACUATION WAS PERFORMED 10/22/97. AT THIS TIME THE WIRES IN THE SQ PATCH WERE FOUND TO BE BROKEN. IT IS UNKNOWN WHEN THIS OCCURRED (SOMETIME SINCE '93 AT THE GENERATOR CHANGE 10/17/97; OR DURING THE HEMATOMA EVACUATION 10/22/97). THE PATCH WAS CAPPED AND THE SYSTEM WAS RECONFIGURED USING THE EXISTING LEADS WITH SUCCESS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARDIAC PACEMAKERS, INC. Implant | SQ PATCH | LWS | CARDIAC PACEMAKERS, INC. | 0063 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |