FDA Adverse Event Death Summary report: N

SEAMED PACING SYSTEM ANALYZER

MDR report key: 161121 · Received April 1, 1998

Report

Report Number: 3019588-1998-00001
Event Type: Death
Date Received: April 1, 1998
Date of Event: February 11, 1998
Report Date: April 1, 1998
Manufacturer: SEAMED CORP.
Product Code: DTC
Removal / Correction Number: NA
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

5/27/1998 S/N 38611 THE DEVICE WAS RECEIVED WITH THE CUSTOMER COMPLAINT "VOLTAGE OUTPUT OUT OF SPECS". DURING INVESTIGATION THE COMPLAINT WAS VERIFIED. THE VENTRICULAR VOLTAGE OUTPUT WAS OBSERVED TO BE OUSIDE OF SPECIFICATIONS. IN ADDITION, THE DEVICE WAS OBSERVED TO BE OUT OF CALIBRATION AND THE OUTER CASE WAS CRACKED. THE VENTRICULAR VOLTAGE OUPUT MALFUNCTION WAS OBSERVED TO BE CAUSED BY LEAKING DIODE CR22. THE OUTER CASE AND DIODE CR22 WERE REPLACED. THE DEVICE WAS TESTED AND CALIBRATED. THE DEVICE WAS FOUND TO PASS ALL TESTS. NO TRENDS WERE FOUND ASSOCIATED WITH THIS FAILURE DURING THE CORRESPONDING TRENDING PERIOD.

Description of Event or Problem · 1

2/2/98 PACEMAKER REVISION. VERY HIGH THRESHOLD THOUGHT TO BE DUE TO SCARRING OF PT TISSUES. VENTRICULAR LEAD RUPTURED PAPILLARY MUSCLE OF TRICUSPID VALVE. PT UNDERWENT EMERGENT TRICUSPID VALVE REPLACEMENT. SUFFERED FATAL COMPLICATIONS. WHEN SAME PACEMAKER ANALYZER WAS ABOUT TO BE USED ON ANOTHER PT, NOTED VERY ABBERANT READOUTS. REMEMBERED PRIOR CASE AND FELT THAT THIS MAY HAVE CAUSED OR CONTRIBUTED TO PT STATUS (2/11/98). EXPIRED 2/13/98.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SEAMED PACING SYSTEM ANALYZER	PACING SYSTEM ANALYZER	DTC	SEAMED CORP.	3100	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	84 YR		Death