RESTORE ULTRA

MDR report key: 2190839 · Received July 28, 2011

Report

Report Number: 3004209178-2011-05852
Event Type: Injury
Date Received: July 28, 2011
Date of Event: May 1, 2011
Report Date: July 1, 2011
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

IT WAS REPORTED THAT FOLLOWING A REVISION, THE PT WAS NOT FEELING A STIMULATION SENSATION FROM THE OCTAD LEAD. THERE WAS NO STIMULATION SENSATION WHEN REPROGRAMMING WAS ATTEMPTED ON THE LEAD. IMPEDANCES WERE WITHIN NORMAL LIMITS. SEVERAL ELECTRODES SHOWED IMPEDANCES OF 7000 OHMS. A MFR REP WAS GOING TO MEET WITH THE PT ON (B)(6) 2011 TO REPROGRAM. RECHARGING ISSUES WERE ALSO REPORTED. THE ANTENNA LOCATE FEATURE SHOWED BETWEEN 32-40, AND THE USER WAS UNABLE TO ESTABLISH ANY COUPLING BARS. THE PT HAD ANOTHER REVISION ON (B)(6) 2011 TO REVISE THE LEADS AND POCKET SITE. AT THAT TIME THE PT HAD A 2X8 PADDLE LEAD IMPLANTED AND CONNECTED TO HIS EXISTING NEUROSTIMULATOR. THE PRIOR QUADPADDLE LEAD AND EXTENSION WERE LEFT IMPLANTED PER THE SURGEON. ON (B)(6) 2011 THE PT WAS UNABLE TO GET THE DEVICE TO CHARGE. ADD'L INFO STATED THE PT'S STIMULATION WAS GREAT AND THE PT WAS ABLE TO EASILY RECHARGE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	RESTORE ULTRA		LGW	MDT PUERTO RICO OPERATIONS CO., JUNCOS	37712	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	66 YR		Required Intervention	IMPLANTED:\| EXPLANTED:\| EXPLANTED:\| UNK CONVERSION TYPE: MODEL 3550-09, LOT# N0032430\| IMPLANTED:\| PROGRAMMER: MODEL 37743, LOT# NKE166271N\| IMPLANTED:\| EXTENSION: MODEL 37083, LOT# NKC002782N\| EXPLANTED:\| ACCESSORY: MODEL 37752, LOT# NKA151414N\| LEAD: MODEL 3778, LOT# V006975