FDA Adverse Event Injury Summary report: N

RESTORE ADVANCED

MDR report key: 6588467 · Received May 24, 2017

Report

Report Number: 3004209178-2017-10971
Event Type: Injury
Date Received: May 24, 2017
Date of Event: January 1, 2015
Report Date: May 24, 2017
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: LGW
PMA / PMN Number: P840001
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID 3487A-45 LOT# V043081 PRODUCT TYPE LEAD PRODUCT ID 3487A-45 LOT# V043081 PRODUCT TYPE LEAD PRODUCT ID 377645 LOT# V002451 PRODUCT TYPE LEAD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. 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.

Description of Event or Problem · 1

INFORMATION WAS RECEIVED FROM A HEALTHCARE PROFESSIONAL (HCP) REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) FOR DEGENERATIVE DISC DISEASE. IT WAS REPORTED THAT THE PATIENT¿S INS WAS REMOVED IN (B)(6) DUE TO AN INS POCKET ISSUE BUT THE LEADS WERE STILL IMPLANTED. IT WAS UNKNOWN IF THE ROOT CAUSE OF THE REMOVAL WAS DUE TO A PROBLEM WITH THE DEVICE OR THERAPY. THE HCP HAD NO FURTHER INFORMATION REGARDING THE EVENT AND TRIED REACHING OUT TO THE PATIENT¿S LISTED MANAGING HCP BUT THEY HAVE NOT SEEN THE PATIENT AT THAT OFFICE. NO FURTHER COMPLICATIONS WERE REPORTED/ARE ANTICIPATED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
369040	RESTORE ADVANCED	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	LGW	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	37713

Patients

Seq	Age	Sex	Outcome	Treatment
1	69 YR		Required Intervention