FDA Adverse Event Injury Summary report: N

RESTORE ULTRA

MDR report key: 2860822 · Received December 6, 2012

Report

Report Number: 3004209178-2012-11258
Event Type: Injury
Date Received: December 6, 2012
Report Date: November 9, 2012
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: LGW
PMA / PMN Number: P840001
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: KY, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ID 39565-65, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 39286-65, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD, PRODUCT ID 37713, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE IMPLANTABLE NEUROSTIMULATOR. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED ON (B)(6) 2012 THAT THE PATIENT WAS STILL HAVING "A LOT" OF PAIN. THE PATIENT STATED THAT HER HEALTH CARE PROVIDER (HCP) WANTED TO PUT IN A THIRD LEAD AND PUT IT "DOWN LOWER." ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2012 REPORTED THAT THE CAUSE OF THE EVENT WAS A SURGICAL LEAD PLACED IN THE WRONG POSITION. IT WAS SCHEDULED FOR (B)(6) 2012 THAT THE PATIENT WOULD BE "SUPPLEMENTED" WITH A PERCUTANEOUS LEAD. PLEASE SEE MANUFACTURING REPORT #3004209178-2012-09839 FOR A RELATED EVENT. THIS REPORT PERTAINED TO THE PATIENT'S EARLIER LEAD REVISIONS.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	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