FDA Adverse Event Malfunction Summary report: N

INTERSTIM II

MDR report key: 3242827 · Received July 23, 2013

Report

Report Number: 3004209178-2013-12168
Event Type: Malfunction
Date Received: July 23, 2013
Date of Event: June 28, 2013
Report Date: June 28, 2013
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: EZW
PMA / PMN Number: P970004
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 3889, LOT# VA08XPT, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. PRODUCT ID: 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. PRODUCT ID: 3093-33, LOT# VA06XNU, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT DURING AN IMPLANT PROCEDURE THE OPERATING SURGEON ¿COULD NOT GET THE NEW LEAD TO HOLD.¿ IT WAS STATED THAT ¿EVERY TIME THE SURGEON WOULD PULL BACK ON THE LEAD IT WOULD MOVE.¿ IT WAS REPORTED THAT ¿IT WAS ALMOST LIKE THE LEAD DID NOT HAVE TINES ON IT.¿ THE REPORTING MANUFACTURER REPRESENTATIVE REPORTED THEY ¿DID NOT BELIEVE IT WAS DUE TO THE PHYSICIAN¿S TECHNIQUE BUT INSTEAD DUE TO THE LEAD.¿ A SECOND LEAD WAS USED AND ¿RESOLVED THE ISSUE.¿ A SUPPLEMENTAL REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
343277	INTERSTIM II	STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE	EZW	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	3058

Patients

Seq	Age	Sex	Outcome	Treatment
1	50 YR