SPRINT FIDELIS

Report

Report Number: 2649622-2008-00932
Event Type: Injury
Date Received: March 10, 2008
Date of Event: November 6, 2007
Manufacturer: MEDTRONIC PUERTO RICO, INC.
Product Code: LWS
PMA / PMN Number: ASKU
Removal / Correction Number: Z-0067-007
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: PATIENT

Narratives

Additional Manufacturer Narrative · 1

IT WAS REPORTED BY THE PATIENT THAT THE LEAD BROKE, AND HE WAS SHOCKED TWENTY TIMES. THE LEAD WAS REPLACED. INFORMATION WAS SUBSEQUENTLY RECEIVED FROM AN ATTORNEY ALLEGING "PLAINTIFF HAS SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE PHYSICAL INJURIES AND/OR DEATH, SEVERE EMOTIONAL DISTRESS, AND ECONOMIC LOSSES AND CONSEQUENTIAL DAMAGES..." NO SPECIFIC DETAIL REGARDING ALLEGED INJURIES WAS RECEIVED, AND NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. NO CONCLUSION CAN BE DRAWN DEVICE BREAKAGE SHOCK, INAPPROPRIATE.

Description of Event or Problem · 1

IT WAS REPORTED BY THE PATIENT THAT THE LEAD BROKE, AND HE WAS SHOCKED TWENTY TIMES. THE LEAD WAS REPLACED. INFORMATION WAS SUBSEQUENTLY RECEIVED FROM AN ATTORNEY ALLEGING "PLAINTIFF HAS SUSTAINED AND WILL CONTINUE TO SUSTAIN SEVERE PHYSICAL INJURIES AND/OR DEATH, SEVERE EMOTIONAL DISTRESS, AND ECONOMIC LOSSES AND CONSEQUENTIAL DAMAGES..." NO SPECIFIC DETAIL REGARDING ALLEGED INJURIES WAS RECEIVED, AND NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SPRINT FIDELIS	IMPLANTABLE TACHY LEAD	LWS	MEDTRONIC PUERTO RICO, INC.	6949	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1	73 YR		Required Intervention	7297 IMPLANTABLE PACEMAKER/CARDIO/DEFIB\| 4194 IMPLANTABLE PACING LEAD\| 5076 IMPLANTABLE PACING LEAD