SURESCAN

MDR report key: 5365124 · Received January 13, 2016

Report

Report Number: 3004209178-2016-00502
Event Type: Malfunction
Date Received: January 13, 2016
Date of Event: September 22, 2015
Report Date: December 22, 2015
Manufacturer: MEDTRONIC PUERTO RICO OPERATIONS CO.
Product Code: LGW
PMA / PMN Number: P840001
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4).

Description of Event or Problem · 1

THE MANUFACTURER REPRESENTATIVE (REP) REPORTED AN OPEN ON ELECTRODE 0 AND A LACK OF GOOD COVERAGE SINCE IMPLANT. ELECTRODE 0 WAS GREATER THAN 20000 OHMS AT 0.7 VOLTS AND 1.5 VOLTS. AT 3.0 VOLTS, THE RESULTS WERE AS FOLLOWS: ELECTRODE 0/1: 20000, 0/2: 13913, 0/3: 13739, 0/4: 14302, 0/5: 13492, 0/6: 13561, 0/7: 20312, 0/8: 20312, 0/9: 14046, 0/10: 13729, 0/11: 12893, 0/12: 13492, 0/13: 19951, 0/14: 14636, AND 0/15: 14638 OHMS. ALL ELECTRODES WERE NORMAL WITH 0 BEING HIGH. THE REP TRIED PROGRAMMING ON 0/8 AND THE PATIENT FELT NOTHING AT 10.5 VOLTS. STIMULATION WAS ON AND NO TRAUMA/FALLS OR INTERFERENCE HAD OCCURRED. NO SYMPTOMS OCCURRED WITH STIMULATION OFF OR WITH POSITIONAL MOVEMENT. THE PATIENT NEEDED COVERAGE ON THE LEFT, LOW BACK AND DOWN LEG. THE PATIENT HAD BEEN PROGRAMMED BEFORE THE APPOINTMENT ON (B)(6) AND HAD STIMULATION BUT NOT THE BEST COVERAGE. IF INCREASED, SHE FELT STIMULATION IN THE WRONG LOCATION. PROGRAMMING AROUND THE HIGH IMPEDANCE WAS REVIEWED. THE REP PALPATED AROUND THE INS. ADDITIONAL STIMULATION WAS NOT FELT BUT THE PATIENT FELT PAIN. RELEVANT MEDICAL HISTORY INCLUDED SPINAL PAIN. NO FOLLOW-UP WAS REQUIRED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
24056	SURESCAN	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	LGW	MEDTRONIC PUERTO RICO OPERATIONS CO.	97714

Patients

Seq	Age	Sex	Outcome	Treatment
1	00069 YR