FDA Adverse Event Malfunction Summary report: N

INTERSTIM II

MDR report key: 5950984 · Received September 14, 2016

Report

Report Number: 3004209178-2016-18934
Event Type: Malfunction
Date Received: September 14, 2016
Report Date: September 14, 2016
Manufacturer: MEDTRONIC MED REL MEDTRONIC PUERTO RICO
Product Code: EZW
PMA / PMN Number: P970004
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: KY, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

SECTION D INFORMATION REFERENCES THE MAIN COMPONENT OF THE SYSTEM AND OTHER APPLICABLE COMPONENTS ARE: PRODUCT ID: 3093-33, LOT# V972782, IMPLANTED: (B)(6) 2013, PRODUCT TYPE: LEAD.

Additional Manufacturer Narrative · 1

IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

THE CONSUMER VIA A MANUFACTURER REPRESENTATIVE REPORTED THAT THE PATIENT LOVED THE DEVICE, BUT EVERY TIME THEY WENT THROUGH THE SECURITY AT THEIR LOCAL GROCERY STORE, IT GAVE THEM A JOLT. THE PATIENT WENT THROUGH IT VERY QUICKLY. IT WAS UNKNOWN IF ANY ENVIRONMENTAL, EXTERNAL, OR PATIENT FACTORS MAY HAVE LED OR CONTRIBUTED TO THE ISSUE. NO TROUBLESHOOTING WAS PERFORMED AND THE ACTION TAKEN TO RESOLVE THE ISSUE WAS THAT THE MANUFACTURER REPRESENTATIVE SUGGESTED THE PATIENT FOLLOW-UP WITH THEIR HEALTH CARE PROVIDER (HCP). THE ISSUE WAS NOT RESOLVED AT THIS TIME. NO SURGICAL INTERVENTION OCCURRED AND NO SURGICAL INTERVENTION WAS PLANNED. THE PATIENT WAS ALIVE WITH NO INJURY. THE INDICATIONS FOR USE FOR THIS PATIENT WERE URINARY DYSFUNCTION/SACRAL NERVE STIMULATION AND GASTROINTESTINAL/PELVIC FLOOR.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
602545	INTERSTIM II	STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE	EZW	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	3058

Patients

Seq	Age	Sex	Outcome	Treatment
1