FDA Adverse Event Injury Summary report: N

REVO MRI SURESCAN

MDR report key: 3863246 · Received June 10, 2014

Report

Report Number: 3004209178-2014-10996
Event Type: Injury
Date Received: June 10, 2014
Date of Event: April 15, 2014
Report Date: April 24, 2014
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: WA, US
Reporter Occupation: HEALTH PROFESSIONAL

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 PRODUCT: 5086MRI52 LEAD IMPLANTED: (B)(6) 2011. (B)(4).

Additional Manufacturer Narrative · 1

PRODUCT EVENT SUMMARY: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. HOWEVER, PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS RECEIVED AND ANALYZED. ANALYSIS OF THE DEVICE MEMORY INDICATED A PARTIAL ELECTRICAL RESET. CRITICAL RAM PARITY ERROR OCCURRED IN ADDRESS 00 B2 ON 2014-(B)(6). POWER ON RESET (POR) SEVERITY IS LOW SO THE DEVICE SHOULD BE ABLE TO FULLY RECOVER AFTER RESET. PATIENT IS UNDERGOING RADIATION THERAPY.

Additional Manufacturer Narrative · 1

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

Description of Event or Problem · 1

IT WAS REPORTED THAT THE IMPLANTABLE PULSE GENERATOR (IPG) EXPERIENCED AN ELECTRICAL RESET. THE RESET WAS CLEARED AND THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
339204	REVO MRI SURESCAN	PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE	LWP	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	RVDR01

Patients

Seq	Age	Sex	Outcome	Treatment
1	00080 YR		Required Intervention	5086MRI58 LEAD