RESTORE PRIME

MDR report key: 1926262 · Received November 11, 2010

Report

Report Number: 3004209178-2010-09261
Event Type: Malfunction
Date Received: November 11, 2010
Date of Event: November 1, 2010
Report Date: November 4, 2010
Manufacturer: MDT PUERTO RICO OPERATIONS CO., JUNCOS
Product Code: LGW
PMA / PMN Number: P840001
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

SEE MANUFACTURER # 3004209178201009262. THE PATIENT EXPERIENCED INADEQUATE STIMULATION RELIEF A COUPLE DAYS AGO. HE WAS SCHEDULED TO HAVE HIS DEVICE REPROGRAMMED, BUT A FLUOROSCOPY FROM 2 DAYS AGO INDICATED MIGRATION ON ALL 6 LEADS. THE 2 EPIDURAL LEADS COMPLETELY RETRACTED INTO THE BATTERY POCKET. THE 4 PERIPHERAL LEADS PULLED IN THE MIDLINE INCISION. THE LEADS HAD BEEN WELL ANCHORED AND THE INSS HAD BEEN SECURED WITH 2 ETHIBOND SUTURES WHICH WERE RECOMMENDED. THE PATIENT UNDERWENT AGGRESSIVE GASTRIC BYPASS AND THE PHYSICIAN FELT THAT COULD BE RESPONSIBLE FOR THE LACK OF HEALING. THE PATIENT WAS REFERRED TO A NEUROSURGEON FOR FURTHER CONSIDERATION. FURTHER INFORMATION HAS BEEN REQUESTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	RESTORE PRIME		LGW	MDT PUERTO RICO OPERATIONS CO., JUNCOS	37701	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	41 YR			IMPLANTED:\| LEAD: MODEL 3888, LOT# V468720\| IMPLANTED:\| LEAD: MODEL 3778, LOT# V453763009\| LEAD: MODEL 3888, LOT# V468720\| IMPLANTED:\| IMPLANTED:\| IMPLANTABLE NEURO STIMULATOR: MODEL 37701\| EXTENSION: MODEL 37082, LOT# NKB002708V\| IMPLANTED:\| EXPLANTED:\| LEAD: MODEL 3888, LOT# V389412\| EXPLANTED:\| IMPLANTED:\| EXPLANTED:\| EXPLANTED:\| IMPLANTED:\| LEAD: MODEL 3888, LOT# V468720\| EXPLANTED:\| IMPLANTED:\| LOT# NKD701787H\| EXPLANTED:\| LEAD: MODEL 3778, LOT# V453763010\| EXPLANTED:\| EXPLANTED:\| IMPLANTED:\| EXTENSION: MODEL 37082, LOT# NKB003802V\| EXPLANTED: