FDA Adverse Event Injury Summary report: N

RESTORE PRIME

MDR report key: 2627883 · Received June 25, 2012

Report

Report Number: 3004209178-2012-04825
Event Type: Injury
Date Received: June 25, 2012
Report Date: May 29, 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: CA, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ID 748910, LOT# SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: PRODUCT TYP EXTENSION PRODUCT ID 748910, LOT# SERIAL# (B)(4), IMPLANTED: (B)(6) 2005, EXPLANTED: PRODUCT TYP EXTENSION PRODUCT ID 37743, LOT# SERIAL# (B)(4), IMPLANTED: EXPLANTED: PRODUCT TYP PROGRAMMER, PATIENT PRODUCT ID 3708220, LOT# SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: PRODUCT TYP EXTENSION PRODUCT ID 3708220, LOT# SERIAL# (B)(4), IMPLANTED: (B)(6) 2011, EXPLANTED: PRODUCT TYP EXTENSION PRODUCT ID 3093-28, LOT# J0555535V, SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYP LEAD PRODUCT ID 3093-28, LOT# J0555535V, SERIAL# IMPLANTED: EXPLANTED: PRODUCT TYP LEAD PRODUCT ID 3093-28, LOT# V800435, SERIAL# IMPLANTED: (B)(6) 2011, EXPLANTED: PRODUCT TYP LEAD. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THE PATIENT NEVER HAD THERAPEUTIC EFFECT. HE WAS STILL HAVING SYMPTOMS OF URINARY FREQUENCY. THIS BEGAN FOLLOWING A REPLACEMENT. THE PATIENT STATED THE HEALTH CARE PROVIDER DID NOT CONNECT ANY OF THE LEFT LEADS. PATIENT OUTCOME WAS NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	RESTORE PRIME	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	LGW	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	37701

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention