FDA Adverse Event Injury Summary report: N

SURESCAN

MDR report key: 3915667 · Received July 7, 2014

Report

Report Number: 3004209178-2014-12579
Event Type: Injury
Date Received: July 7, 2014
Report Date: June 14, 2014
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: IN, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 977A260, SERIAL# (B)(4), IMPLANTED: (B)(6) 2014, PRODUCT TYPE: LEAD; PRODUCT ID 97754, SERIAL# (B)(4), PRODUCT TYPE: RECHARGER; PRODUCT ID 97740, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THERE WAS METAL POKING THROUGH THE PATIENT¿S SKIN AT THE LEAD SITE. ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE PATIENT WAS HAVING SURGERY ON THE DAY OF THIS REPORT TO HAVE A PORTION OF HER LEADS REMOVED. IT WAS STATED THAT THE LEADS HAD ERODED THROUGH THE PATIENT¿S SKIN. IT WAS NOTED THAT THERE HAD BEEN A PLAN TO PUT THE PATIENT ON ANTIBIOTICS FOR A ¿PERIOD OF TIME¿ AND THEN REPLACED THE LEADS AT A LATER DATE. IT WAS FURTHER NOTED THAT THE LEAD REPLACEMENT DATE HAD NOT BEEN SPECIFIED.

Description of Event or Problem · 1

FOLLOW UP INFORMATION RECEIVED REPORTED THAT THE EXPLANTED PORTIONS OF THE LEADS WERE NOT RETURNED TO THE MANUFACTURER PER THE PHYSICIAN. THE PATIENT WAS REPORTED AS DOING FINE. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW UP REPORT WILL BE SENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
393902	SURESCAN	STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)	LGW	MEDTRONIC PUERTO RICO OPERATIONS CO.	97714

Patients

Seq	Age	Sex	Outcome	Treatment
1	00039 YR		Required Intervention