FDA Adverse Event
Malfunction
Summary report: N
ENDOTAK DSP
MDR report key: 293822
·
Received August 8, 2000
Report
- Report Number
- 2124215-2000-01988
- Event Type
- Malfunction
- Date Received
- August 8, 2000
- Date of Event
- May 20, 2000
- Report Date
- May 20, 2000
- Manufacturer
- CARDIAC PACEMAKERS
- Product Code
- LWS
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- LAY USER/PATIENT
Narratives
Description of Event or Problem · 1
EVENT DESCRIPTION CPI RECEIVED INFORMATION THAT THIS IMPLANTABLE PULSE GENERATOR (IPG) COULD NOT BE INTERROGATED FOLLOWING A SERIES OF SHOCKS THE PATIENT RECEIVED FROM AN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD). BOTH PULSE GENERATORS WERE REMOVED AND UPGRADED TO A DUAL CHAMBER AICD. THE LEAD, MODEL 125, SERIAL NUMBER 201926 WAS REMOVED DUE TO A FRACTURE AT THE TERMINAL PIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOTAK DSP | TRANSVENOUS DEFIBRILLATION LEAD | LWS | CARDIAC PACEMAKERS | 0125 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Other | THE DEVICE 0155/202235 WAS IMPLANTED 23-MAY-2000| THE DEVICE 1740/101883 WAS IMPLANTED 28-MAR-1996| THE DEVICE 4271/202316 WAS IMPLANTED 26-MAR-1996| THE DEVICE 4261/237518 WAS IMPLANTED 26-MAR-1996| THE DEVICE 1851/306467 WAS IMPLANTED 23-MAY-2000| THE DEVICE 0154/203230 WAS IMPLANTED 23-MAY-2000| THE DEVICE 0940/703865 WAS IMPLANTED 26-MAR-1996 |