SPRINT

Report

Report Number: 2182208-2010-00624
Event Type: Injury
Date Received: September 14, 2010
Manufacturer: MEDTRONIC, INC.
Product Code: LWS
PMA / PMN Number: P920015/S12
Removal / Correction Number: ASKU
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS INFORMATION IS BASED ENTIRELY ON JOURNAL LITERATURE. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. WITHOUT A LOT NUMBER OR DEVICE SERIAL NUMBER, THE MANUFACTURING DATE CANNOT BE DETERMINED. SINCE NO DEVICE ID WAS PROVIDED, IT IS UNKNOWN IF THIS EVENT HAS BEEN PREVIOUSLY REPORTED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS LIMITED DUE TO CONFIDENTIALITY CONCERNS. REFERENCED ARTICLE: "INAPPORPRIATE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR DISCHARGE FROM SENSING OF EXTERNAL ALTERNATING CURRENT LEAK." JOURNAL OF INTERVENTIONAL CARDIAC ELECTROPHYSIOLOGY. 2002; 7:181-184.

Description of Event or Problem · 1

A JOURNAL ARTICLE WAS REVIEWED THAT CONTAINED INFORMATION REGARDING THIS DEVICE AND LEAD. IT WAS REPORTED THAT THE PATIENT HAD RECEIVED INAPPROPRIATE SHOCKS DUE TO THE "ABNORMAL SENSING OF EXTERNAL NOISE." THE INAPPROPRIATE SHOCKS OCCURRED ONLY WHEN THE PATIENT WAS IN CONTACT WITH WATER (A SWIMMING POOL OR SHOWER). THE ARTICLE INDICATED THAT THESE WERE TRIGGEREDY BY "MINIMAL ELECTRICAL CURRENT LEAD RESEMBLING VF." THE DEVICE AND THE LEADS WERE REPLACED. THE ARTICLE STATED THAT THE DEVICE WAS EVALUATED AND THERE WAS "NO EVIDENCE OF DEVICE MALFUNCTION." FURTHER FOLLOW-UP DID NOT YIELD ANY ADDITIONAL RELEVANT INFORMATION REGARDING THIS EVENT. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SPRINT	IMPLANTABLE TACHY LEAD	LWS	MEDTRONIC, INC.	6942	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1	10 YR		Required Intervention