FDA Adverse Event Injury Summary report: N

DELTA

MDR report key: 3951020 · Received July 22, 2014

Report

Report Number: 2124215-2014-11140
Event Type: Injury
Date Received: July 22, 2014
Date of Event: November 7, 2013
Report Date: November 7, 2013
Manufacturer: HISTORICAL CPI ST. PAUL
Product Code: DXY
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

UPON RECEIPT AT OUR POST MARKET QUALITY ASSURANCE LABORATORY, A THOROUGH EVALUATION OF THE DEVICE WAS EVALUATED. A VISUAL INSPECTION OF THE DEVICE HEADER AND CASE NOTED NO ANOMALIES. DRIED BODY FLUID CONTAMINATION IN BOTH LEAD BARRELS WAS OBSERVED. ALL FOUR SET SCREWS MOVED NORMALLY IN BOTH DIRECTIONS. IT WAS CONFIRMED THAT THIS DEVICE EXCEEDED THE EXPECTED LONGEVITY. NEXT, A COMPREHENSIVE SERIES OF DIAGNOSTIC TESTS WERE CONDUCTED THAT VERIFIED THE PERFORMANCE OF THERAPY DELIVERY, SENSING, AND RECORDING FUNCTIONS. MANUAL THRESHOLD TESTING WAS PERFORMED ON THE DEVICE WITH NO PAUSES IN PACING. ANALYSIS CONCLUDED THAT THIS DEVICE EXPERIENCED NORMAL BATTERY DEPLETION. LABORATORY ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED CLINICAL OBSERVATIONS.

Description of Event or Problem · 1

BOSTON SCIENTIFIC RECEIVED INFORMATION THAT THIS PACEMAKER DID NOT DELIVER PACING PULSES FOR APPROXIMATELY 12 SECONDS AFTER THRESHOLD TESTING HAD ENDED. THE PATIENT EXPERIENCED ASYSTOLE DURING THE 12 SECONDS OF PACING INHIBITION AND FELT DIZZY BUT DID NOT LOSE CONSCIOUSNESS. AT THE LAST FOLLOW UP APPROXIMATELY 90 DAYS PRIOR, THE DEVICE HAD A BATTERY STATUS OF ELECTIVE REPLACEMENT INDICATOR (ERI). THE DEVICE WAS EXPLANTED AND REPLACED WITHOUT INCIDENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
428241	DELTA	IMPLANTABLE PULSE GENERATOR	DXY	HISTORICAL CPI ST. PAUL	0927

Patients

Seq	Age	Sex	Outcome	Treatment
1	76 YR		Hospitalization\| L\| R	4160\| 5826\| MISMATCH\| 4170\| 0927