FDA Adverse Event Malfunction Summary report: N

RESTORE ULTRA

MDR report key: 3813161 · Received May 15, 2014

Report

Report Number: 3004209178-2014-09037
Event Type: Malfunction
Date Received: May 15, 2014
Date of Event: April 2, 2014
Report Date: April 23, 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: OK, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 37743, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3708140, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 3778-45, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: LEAD. PRODUCT ID: 37752, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT HAD NOT BEEN ABLE TO USE HER STIMULATOR IN 3 WEEKS. THE PATIENT HAD MAJOR STOMACH SURGERY 3 WEEKS PRIOR, WHICH WAS UNRELATED TO THE STIMULATOR, IN WHICH SHE HAD HALF OF HER STOMACH REMOVED. THE PATIENT STATED THE STIMULATION GOES DOWN HER LEGS, BUT SHE ALSO FEELS IT IN HER STOMACH EVEN AT THE LOWEST SETTING, SO SHE WAS UNABLE TO USE IT. THE PATIENT HAD TRIED TO HAVE HER PHYSICIAN REQUEST A COMPANY REPRESENTATIVE FOR A VISIT, BUT HAD NOT BEEN SUCCESSFUL. ADDITIONAL INFORMATION WAS REQUESTED, IF RECEIVED A FOLLOW UP REPORT WILL BE SENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
290971	RESTORE ULTRA	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	LGW	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	37712

Patients

Seq	Age	Sex	Outcome	Treatment
1	00042 YR