FDA Adverse Event Injury Summary report: N

INTERSTIM II

MDR report key: 3827565 · Received May 22, 2014

Report

Report Number: 3007566237-2014-01414
Event Type: Injury
Date Received: May 22, 2014
Report Date: April 30, 2014
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

CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3886, LOT# J0217132V, IMPLANTED: (B)(6) 2002, PRODUCT TYPE: LEAD. PRODUCT ID 3095-10, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009, PRODUCT TYPE: EXTENSION. PRODUCT ID 3037, SERIAL# (B)(4), PRODUCT TYPE: PROGRAMMER, PATIENT. (B)(4).

Additional Manufacturer Narrative · 1

PMA # CORRECTED TO P970004.

Additional Manufacturer Narrative · 1

CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 3886, LOT# J0217132V, PRODUCT TYPE LEAD. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT THE LEAD WAS REVISED FOR SYSTEM UPGRADE. IT WAS ALSO REPORTED ¿LEAD IMPEDANCES¿ AND REPLACED WITH NEW LEAD.

Description of Event or Problem · 1

ADDITIONAL INFORMATION RECEIVED REPORTED THAT THE CAUSE OF THE IMPEDANCE ISSUE WAS UNKNOWN. THE HEALTHCARE PROVIDER (HCP) DID NOT THINK IT WAS RELATED TO A MALFUNCTION OF THE IMPLANTABLE NEUROSTIMULATOR (INS), BUT RATHER A PATIENT FALL OR ANOTHER ISSUE. THE HCP WAITED UNTIL THE INS REACHED NORMAL END OF LIFE (EOL) AND REPLACED THE INS AS WELL AS THE LEAD TO CORRECT THE IMPEDANCE ISSUE. THE IMPEDANCE ISSUE WAS CORRECTED AND THE PATIENT RECOVERED AND WAS EXPERIENCING APPROPRIATE THERAPY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
306115	INTERSTIM II	STIMULATOR, ELECTRICAL, IMPLANTABLE, FOR INCONTINENCE	EZW	MEDTRONIC MED REL MEDTRONIC PUERTO RICO	3058

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention