FDA Adverse Event Malfunction Summary report: N

EXTERNAL PULSE GENERATOR

MDR report key: 2791213 · Received October 15, 2012

Report

Report Number: 2183613-2012-01702
Event Type: Malfunction
Date Received: October 15, 2012
Date of Event: June 23, 2012
Manufacturer: MEDTRONIC MILACA INC.
Product Code: DTE
PMA / PMN Number: P820003/S72
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: MA, US
Reporter Occupation: BIOMEDICAL ENGINEER

Narratives

Additional Manufacturer Narrative · 1

THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) - ANALYSIS CONFIRMED THE REPORTED EVENT. SCREEN OF LCD (LIQUID CRYSTAL DISPLAY) WAS NOT WORKING DUE TO A LOOSE CONNECTION. CONNECTOR LATCH OF THE LCD IS BROKEN. NO SILICONE ON THE BROKEN LATCH SIDE OF THE CONNECTOR. IT IS NOTED THAT THE CUSTOMER TAMPERED WITH THE DEVICE. LCD SCREW IS MISSING. UPPER AND LOWER CASES AND SIDE BAIL COVERS ARE BROKEN. RING COVER IS CONTAMINATED. THE RING IS BENT. BATTERY DRAWER HAS A COSMETIC DENT. KEYBOARD IS SCRATCHED (COSMETIC).

Description of Event or Problem · 1

IT WAS REPORTED THE MENU SCREEN OF THE EPG (EXTERNAL PULSE GENERATOR) WAS NOT WORKING. THE CONNECTOR FOR THE RIBBON CABLE ON THE PCB (PRINTED CIRCUIT BOARD) WAS FOUND TO BE BROKEN. THE EPG WAS RETURNED FOR REPAIR. NO PATIENT INVOLVEMENT OR COMPLICATIONS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1		EXTERNAL PULSE GENERATOR	DTE	MEDTRONIC MILACA INC.	5388

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other