FDA Adverse Event Injury Summary report: N

RESTORE SENSOR

MDR report key: 2822410 · Received November 7, 2012

Report

Report Number: 3004209178-2012-09988
Event Type: Injury
Date Received: November 7, 2012
Date of Event: August 16, 2012
Report Date: October 9, 2012
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: TX, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD; PRODUCT ID 3778-60, SERIAL# (B)(4), IMPLANTED: 2012 (B)(6), PRODUCT TYPE LEAD; PRODUCT ID 37754, SERIAL# (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 37744, SERIAL# (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 355531, LOT# N339867, IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE SCREENING DEVICE; PRODUCT ID 3550-39, LOT# N310571, IMPLANTED: 2012 (B)(6), EXPLANTED: 2012 (B)(6), PRODUCT TYPE ACCESSORY; (B)(4).

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT HAD TWO ADDITIONAL EXTENSIONS IMPLANTED ON (B)(6) 2012.

Description of Event or Problem · 1

IT WAS REPORTED THE PATIENT HAD POOR COUPLING, AND WAS UNABLE TO FULLY CHARGE THE IMPLANTABLE NEUROSTIMULATOR (INS) DUE TO OBESITY. A SURGICAL REVISION OF THE INS OCCURRED ON (B)(6) 2012, AND AN ADDITIONAL REPROGRAMMING WAS PERFORMED APPROXIMATELY A WEEK LATER. THE PATIENT RECOVERED WITHOUT SEQUELAE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	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	00063 YR		Required Intervention