PROTECTA XT DR

MDR report key: 2810990 · Received October 31, 2012

Report

Report Number: 6000144-2012-06414
Event Type: Malfunction
Date Received: October 31, 2012
Date of Event: July 9, 2012
Report Date: December 14, 2012
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: LWS
PMA / PMN Number: P980016/S218
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NJ, US
Reporter Occupation: PATIENT FAMILY MEMBER OR FRIEND

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Additional Manufacturer Narrative · 1

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED BY THE PATIENT'S SPOUSE THAT THE PATIENT IS FEELING LIKE "GRAVITY PULLING OVER" THE PATIENT'S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DEVICE AND IT WAS "VERY TIGHT" OVER ICD DEVICE DURING A DEVICE CHECK. THE PATIENT'S SPOUSE ALSO REPORTED THAT "REDNESS" WAS NOTED AT POST ICD CHECK, BUT NOTED THAT THE MEDICAL STAFF WAS NOT CONCERNED. THE PATIENT'S SPOUSE THOUGHT IT MIGHT BE AN INFECTION, BUT THE SITE IS NOT RED ANYMORE. THE PATIENT'S SPOUSE ALSO STATED THAT THE PATIENT HAD BEEN LIGHTHEADED AND THE PATIENT'S VISION HAD BEEN DIFFERENT AT TIMES. ADDITIONAL INFORMATION WAS ATTEMPTED TO BE OBTAINED FROM THE CLINICIAN, HOWEVER, IT WAS NOT AVAILABLE. THE ICD DEVICE REMAINS IN USE. 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	PROTECTA XT DR	DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER	LWS	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	D314DRM

Patients

Seq	Age	Sex	Outcome	Treatment
1	83 YR		Other	5076 IMPLANTABLE PACING LEAD\| (B)(4) IMPLANTABLE TACHY LEAD