FDA Adverse Event Malfunction Summary report: N

ASKU

MDR report key: 1990103 · Received February 15, 2011

Report

Report Number: 2182208-2011-00121
Event Type: Malfunction
Date Received: February 15, 2011
Date of Event: September 9, 2010
Report Date: November 29, 2011
Manufacturer: MEDTRONIC, INC.
Product Code: DTB
PMA / PMN Number: K960446
Removal / Correction Number: ASKU
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FS
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS EVENT OCCURRED OUTSIDE THE U.S. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS.

Additional Manufacturer Narrative · 1

PRODUCT EVENT SUMMARY: ANALYSIS COULD NOT CONFIRM THE REPORTED EVENT. NO ANOMALIES WERE FOUND. ALL CABLE CONTINUITY TESTS PASSED, WITH NO INTERMITTENT CONNECTIONS NOTED. (B)(4).

Description of Event or Problem · 1

IT WAS REPORTED THAT "IT WAS NOT POSSIBLE TO STIMULATE/DETECT THE HEART WITH THIS DISPOSABLE SURGICAL CABLE." NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Description of Event or Problem · 1

IT WAS REPORTED THAT THERE WAS "DEFECTIVE DETECTION AND STIMULATION" WITH THE PATIENT CABLE. THE CABLE WAS RETURNED FOR REPAIR. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT, AND THE PATIENT OUTCOME WAS REPORTED AS FINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ASKU	CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)	DTB	MEDTRONIC, INC.	5487	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other\| R	EXTERNAL PULSE GENERATOR