FDA Adverse Event Injury Summary report: N

REVO MRI SURESCAN

MDR report key: 3990516 · Received August 8, 2014

Report

Report Number: 3004209178-2014-14437
Event Type: Injury
Date Received: August 8, 2014
Date of Event: June 26, 2014
Report Date: July 11, 2018
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: LWP
PMA / PMN Number: P090013
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. CONCOMITANT MEDICAL PRODUCTS: 5086MRI45 LEAD, IMPLANTED: (B)(6) 2011. (B)(4).

Additional Manufacturer Narrative · 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative · 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative · 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative · 1

PRODUCT EVENT SUMMARY: THE DEVICE WAS RETURNED AND ANALYZED. THE RETURNED DEVICE INDICATED LOCK-UP IN AN INTEGRATED CIRCUIT.

Description of Event or Problem · 1

IT WAS FURTHER REPORTED THAT THE PATIENT IS A PARTICIPANT IN THE (B)(4) STUDY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE DEVICE EXPERIENCED EARLY BATTERY DEPLETION. THE DEVICE WAS EXPLANTED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
468576	REVO MRI SURESCAN	PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE	LWP	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	RVDR01

Patients

Seq	Age	Sex	Outcome	Treatment
1	00065 YR		Hospitalization\| R	5086MRI52 LEAD