FDA Adverse Event Injury Summary report: N

RESTORE SENSOR

MDR report key: 6109158 · Received November 17, 2016

Report

Report Number: 3004209178-2016-24214
Event Type: Injury
Date Received: November 17, 2016
Date of Event: August 1, 2016
Report Date: November 17, 2016
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: LGW
UDI-DI: 00613994610430
PMA / PMN Number: P840001
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MO, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND THE OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3487A-56, LOT# V931748, IMPLANTED: (B)(6) 2013M PRODUCT TYPE: LEAD. PRODUCT ID: 3487A-56, LOT# V999674, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, 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 CONSUMER REGARDING A PATIENT WITH AN IMPLANTABLE NEUROSTIMULATOR (INS) INDICATED FOR FAILED BACK SURGERY SYNDROME AND SPINAL PAIN. IT WAS REPORTED THAT THE PATIENT HAD THEIR SECOND SYSTEM EXPLANTED AFTER THE WIRES WERE CUT DURING AN UNRELATED SPINAL FUSION SURGERY. A SMALL SEGMENT OF THE LEAD WAS LEFT IMPLANTED BECAUSE THE HEALTHCARE PROFESSIONAL WAS AFRAID OF REMOVING THE PORTION THAT WAS IN THE SPINAL COLUMN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
760458	RESTORE SENSOR	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	LGW	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	37714		00613994610430

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention