FDA Adverse Event Injury Summary report: N

PATCH

MDR report key: 1781654 · Received August 3, 2010

Report

Report Number: 2124215-2010-14677
Event Type: Injury
Date Received: August 3, 2010
Date of Event: April 27, 2010
Report Date: November 4, 2010
Manufacturer: CPI - DEL CARIBE
Product Code: NHW
PMA / PMN Number: P910077
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

AS OF TODAY, ALL AVAILABLE INFORMATION INDICATES THAT THIS LEAD REMAINS IN SERVICE. AT THIS TIME, NO ADDITIONAL INFORMATION IS AVAILABLE. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THIS REPORT WILL BE UPDATED.

Description of Event or Problem · 1

SUBSEQUENT INFORMATION INDICATES THAT THE PATIENT UNDERWENT A NON-INVASIVE PROGRAMMED STIMULATION (NIPS) STUDY TO ASSES THE SYSTEM. THIS RESULTED IN A 56 OHM SHOCK IMPEDANCE MEASUREMENT. THE SYSTEM WILL CONTINUE TO BE MONITORED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

Description of Event or Problem · 1

BOSTON SCIENTIFIC CRM RECEIVED INFORMATION THAT THE PATIENT WITH THIS EPICARDIAL PATCH LEAD AND THE ASSOCIATED IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) REPORTED HEARING TONES. TECHNICAL SERVICES (TS) DISCUSSED USING LATITUDE TO PERFORM AN INTERROGATION TO CHECK FOR THE SOURCE OF TONES. LATITUDE INDICATED THAT A HIGH, OUT OF RANGE SHOCK IMPEDANCE MEASUREMENT HAD OCCURRED. TS RECOMMENDED BRINGING THE PATIENT IN FOR FURTHER EVALUATION. THE PATIENT WAS BROUGHT IN TO THE CLINIC FOR FOLLOW UP. THE LOCAL FIELD REPRESENTATIVE (FR) REPORTED THAT THEY WERE UNABLE TO REPRODUCE ANY PROBLEMS. THE PLAN WAS TO INCREASE CHECKS TO MONTHLY. NO ADVERSE PATIENT EFFECTS HAVE BEEN REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	PATCH	IMPLANTABLE LEAD	NHW	CPI - DEL CARIBE	0067

Patients

Seq	Age	Sex	Outcome	Treatment
1	62 YR		Required Intervention	T167\| 0064\| T180\| 1858\| 4046\| 4968\| 0067\| 0068\| 1625\| 1789