FDA Adverse Event Injury Summary report: N

SURESCAN

MDR report key: 3820973 · Received May 20, 2014

Report

Report Number: 3004209178-2014-09263
Event Type: Injury
Date Received: May 20, 2014
Report Date: May 12, 2014
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 Location: MT, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT PRODUCTS: PRODUCT ID: 39565-65, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: NEU _RECHARGER_ACC, PRODUCT TYPE: RECHARGER. PRODUCT ID: NEU_PTM_PROG, PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THERE WAS A COUPLING PROBLEM AND THE PATIENT WAS GETTING TWO BARS AT THE BEST OR LOST COUPLING. IT WAS NOTED THAT AT THE TIME OF THE REPORT, THE IMPLANTABLE NEUROSTIMULATOR (INS) HAD LOST ITS CHARGE AND THE PATIENT WAS NOT GETTING STIMULATION AT THAT TIME. THE REPORTER NOTED THAT HE DIDN¿T KNOW HOW THE INS WAS SITTING IN THE POCKET, BUT INDICATED THAT THE PATIENT WAS HEALED UP. ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD NOTHING BUT PROBLEMS SINCE IMPLANT. THE REPORTER STATED THE IMPLANTABLE NE UROSTIMULATOR (INS) WAS INITIALLY TILTED SO THE PATIENT¿S HEALTHCARE PROFESSIONAL (HCP) WENT BACK IN TO ¿TACK IT DOWN¿ ON THE RIGHT SIDE IN (B)(6) 2013. THE REPORTER FURTHER STATED THAT SINCE THEN THE INS CHARGED REALLY WELL. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
299919	SURESCAN	STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)	LGW	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	97714

Patients

Seq	Age	Sex	Outcome	Treatment
1	00082 YR		Required Intervention