FDA Adverse Event Injury Summary report: N

RESTORE SENSOR

MDR report key: 3020026 · Received March 25, 2013

Report

Report Number: 3004209178-2013-04210
Event Type: Injury
Date Received: March 25, 2013
Report Date: March 6, 2013
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: ND, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: EXTENSION: PRODUCT ID 3708120, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: EXTENSION: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD: PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012, EXPLANTED: (B)(6) 2013. PRODUCT TYPE: LEAD: PRODUCT ID 37754, SERIAL# (B)(4). PRODUCT TYPE: RECHARGER: PRODUCT ID 37744, SERIAL# (B)(4). PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THE PATIENT'S LEADS AND EXTENSIONS HAD MIGRATED AND BOTH OF THE LEADS AND BOTH EXTENSIONS WERE REPLACED WITH NEW ONES. IT WAS ALSO REPORTED "THERE WAS NOTHING WRONG WITH THE OLD LEADS AND EXTENSIONS EXCEPT FOR MIGRATION". THE PROBLEM WAS REPORTEDLY RESOLVED AFTER THE REVISION. THERE WERE NO PATIENT SYMPTOMS OR INJURIES RELATED TO THIS EVENT. IT WAS ALSO STATED THE PATIENT WAS ALIVE WITH NO INJURY OR ADVERSE EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
122869	RESTORE SENSOR	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	LGW	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	37714

Patients

Seq	Age	Sex	Outcome	Treatment
1	00057 YR		Required Intervention