FDA Adverse Event Injury Summary report: N

INTERSTIM II

MDR report key: 2626335 · Received June 22, 2012

Report

Report Number: 3004209178-2012-04778
Event Type: Injury
Date Received: June 22, 2012
Report Date: May 24, 2012
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: MN, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

PRODUCT ID 3093-28 LOT# V867752 SERIAL# IMPLANTED: (B)(6) 2012 EXPLANTED:; PRODUCT TYP LEAD PRODUCT ID 3037 LOT# SERIAL# (B)(4) IMPLANTED: EXPLANTED:; PRODUCT TYP PROGRAMMER. (B)(4).

Additional Manufacturer Narrative · 1

LEAD MODEL 3093-28, LOT# V840219, IMPLANTED: 2011-(B)(6), EXPLANTED: 2012-(B)(6).

Description of Event or Problem · 1

ADDITIONAL INFORMATION RECEIVED REPORTED THAT IMPEDANCE ISSUES WERE VISUALIZED WITH INTERROGATION OFF THE ORIGINAL LEAD. THE PATIENT HAD SLIPPED AND FALLEN ON HER PORCH AND INDICATED THAT SHE WAS GETTING SHOCKED POST FALL. AFTER SEVERAL 'RE-PROGRAMMING SESSIONS' THE PATIENT CONTINUED TO EXPERIENCE POOR RESULTS AND A DECISION TO REPLACE THE LEAD WAS MADE BY THE SURGEON AND PATIENT. POST REVISION THE PATIENT RETURNED TO GOOD RESULTS AND NO LONGER EXPERIENCED THE SHOCKING SENSATION.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT EXPERIENCED SHOCKING IN THE RECTUM. THE PATIENT HAD LEAD REVISION SURGERY APPROXIMATELY ONE MONTH AGO DUE TO SHOCKING IN THE POCKET. THE PATIENT FELL HARD AND X-RAYS INDICATED THAT THE LEAD HAD MOVED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention