FDA Adverse Event Injury Summary report: N

IMPLANTABLE NEUROSTIMULATOR

MDR report key: 5571191 · Received April 12, 2016

Report

Report Number: 3007566237-2016-01649
Event Type: Injury
Date Received: April 12, 2016
Report Date: April 12, 2016
Manufacturer: MEDTRONIC NEUROMODULATION
Product Code: LGW
PMA / PMN Number: P840001
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: BE
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: NEU_UNKNOWN_LEAD, LOT# UNKNOWN, PRODUCT TYPE: LEAD. PRODUCT ID: 09078, LOT# S2506-09, IMPLANTED: (B)(6) 2014, EXPLANTED: (B)(6) 2014.

Description of Event or Problem · 1

THE HEALTH CARE PROVIDER (HCP) REPORTED VIA THE COMPANY REPRESENTATIVE (REP) THAT THE PATIENT WAS IMPLANTED SEVERAL TIMES IN THE SAME LOCATION WITH OTHER LEADS WITHOUT SUCCESS. IN THE END, THE PATIENT WAS IMPLANTED WITH A CUSTOM LEAD. THE PATIENT EXPERIENCED NO PARESTHESIA AND LACK OF PARESTHESIA AT MAXIMAL AMPLITUDE DUE TO FIBROTIC TISSUE AROUND THE LEAD. NO THERAPY WAS POSSIBLE SHORTLY AFTER IMPLANT. REPROGRAMMING WAS PERFORMED, BUT DIDN'T CHANGE ANYTHING. THE REP REPORTED A WEEK LATER THAT THE ISSUE WAS NOT RESOLVED AFTER REMOVING THE LEAD. THEY TRIED AGAIN WITH REPLACEMENT OF THE LEAD BUT IT SEEMED THE PATIENT REQUIRED SUCH HIGH AMPLITUDES. FURTHER STATED HIGH ENERGY CONSUMPTION DUE TO SUBCUTANEOUS FIBROSIS IN THE OCCIPITAL AREA. THE CAUSE WAS FIBROTIC TISSUE. ADDITIONALLY, STATED THAT THE FIBROTIC TISSUE AROUND THE LEAD WAS CAUSED BY SO MANY REVISIONS IN A ROW. IT WAS NOTED THAT THE LEAD WAS THROWN AWAY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
225719	IMPLANTABLE NEUROSTIMULATOR	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	LGW	MEDTRONIC NEUROMODULATION	NEU_INS_STIMULATOR	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention