FDA Adverse Event Injury Summary report: N

RESTORE ULTRA

MDR report key: 5933260 · Received September 7, 2016

Report

Report Number: 3004209178-2016-18416
Event Type: Injury
Date Received: September 7, 2016
Report Date: September 7, 2016
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: OR, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. PRODUCT ID: 3777-60, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: LEAD. PRODUCT ID: 37092, LOT# 221340003, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: ACCESSORY. PRODUCT ID: 3550-39 LOT# N213345, IMPLANTED: (B)(6) 2009, EXPLANTED: (B)(6) 2016, PRODUCT TYPE: ACCESSORY.

Additional Manufacturer Narrative · 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

THE CONSUMER VIA THE MANUFACTURER REPRESENTATIVE REPORTED THAT THE PATIENT HAD A FULL SYSTEM EXPLANT ON (B)(6) 2016 DUE TO A FALL THAT HAD "MESSED THINGS UP." IT WAS NOTED THAT THE SYSTEM WORKED PRIOR TO THE FALL, AND THE DATE OF THE FALL WAS UNKNOWN. THE CONSUMER REPORTED THAT SHE FELL OUT OF AN RV AND HIT A ROCK, WHICH DESTROYED THE SYSTEM. DIAGNOSTIC TESTING OR TROUBLESHOOTING WAS NOT PERFORMED. IT WAS UNKNOWN WHETHER THE PATIENT RECOVERED COMPLETELY. THE PATIENT'S INDICATIONS FOR USE INCLUDED POST LUMBAR LAMINECTOMY SYNDROME.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
585569	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			Required Intervention