FDA Adverse Event Malfunction Summary report: N

SURESCAN

MDR report key: 3770593 · Received April 24, 2014

Report

Report Number: 3004209178-2014-08069
Event Type: Malfunction
Date Received: April 24, 2014
Date of Event: March 31, 2014
Report Date: April 7, 2014
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: MN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT PRODUCTS: PRODUCT ID 97740, SERIAL # (B)(4), PRODUCT TYPE PROGRAMMER, PATIENT; PRODUCT ID 97754, SERIAL # (B)(4), PRODUCT TYPE RECHARGER; PRODUCT ID 977A260, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD; PRODUCT ID 977A260, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE LEAD. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THERE WAS A SHOCKING OR JOLTING SENSATION. IT WAS NOTED THAT THE PATIENT EXPERIENCED SHOCKING/JOLTING A WEEK PRIOR TO REPORT THAT WAS NOT PROMPTED BY FALLS OR TRAUMA. THE CALLER NOTED THAT IT APPEARED CONTACTS 4 AND 7 WERE ¿OUT¿ AND WERE GREATER THAN 10K OHMS. THE CALLER NOTED THAT THEY WOULD PROGRAM AROUND. THE CALLER WAS WITH THE PATIENT AND NEEDED TO GET OFF THE PHONE SO MORE DETAILED INFORMATION COULD BE GATHERED. THE MANUFACTURER REPRESENTATIVE NOTED THAT THEY WERE NOTIFIED ON THE DATE OF REPORT. IT WAS LATER REPORTED THAT THE PATIENT HAD TWO ELECTRODES THAT WERE ¿OUT¿ ON THE 0-7 LEAD. THE MANUFACTURER REPRESENTATIVE NOTED THAT THEY WERE ¿PRIMARILY¿ USING THE 8-15 LEAD AND THE PATIENT HAD GOOD COVERAGE. IT WAS NOTED BY THE MANUFACTURER REPRESENTATIVE THAT THE PATIENT FELL OUT OF A CHAIR AND WONDERED IF THAT WAS THE CAUSE OF THE LEAD FRACTURE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
250054	SURESCAN	STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF	LGW	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	97714

Patients

Seq	Age	Sex	Outcome	Treatment
1	00046 YR