SIGMA 300 DR

Report

Report Number: 2647346-2010-00878
Event Type: Injury
Date Received: December 14, 2010
Manufacturer: MEDTRONIC MED REL, INC.
Product Code: DXY
PMA / PMN Number: P980035/S2
Removal / Correction Number: ASKU
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: PHYSICIAN

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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE.

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 OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION AND THAT THE DEVICE HAS REACHED ELECTIVE REPLACEMENT INDICATOR (ERI) BEFORE IT WAS EXPLANTED. IT WAS NOTED THAT THE DEVICE HAD LIFTED HYBRID BOND WIRES.

Description of Event or Problem · 1

ASKU

Description of Event or Problem · 1

IT WAS REPORTED THAT THE PATIENT, WITH A HISTORY OF COMPLETE HEART BLOCK AND A LOWER RATE LIMIT OF 80 PULSES PER MINUTE, WAS HAVING EPISODES OF TORSADES DUE TO ELECTIVE REPLACEMENT INDICATOR (ERI) PACING RATE OF 65. IT WAS ALSO REPORTED THAT THE PHYSICIAN FELT THAT THE TORSADES WAS RELATED TO THE LOWER ERI RATE. IN ORDER TO MAINTAIN PACING THE PROGRAMMER HEAD WAS TAPPED TO THE PATIENTS CHEST. THE DEVICE WAS EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SIGMA 300 DR	IMPLANTABLE PULSE GENERATOR	DXY	MEDTRONIC MED REL, INC.	SDR303	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1	47 YR		Hospitalization\| L\| R	5071 (X3) IMPLANTABLE PACING LEAD\| (B)(4) IMPLANTABLE LEAD ADAPTOR\| 5071 (X3) IMPLANTABLE PACING LEAD\| (B)(4) IMPLANTABLE LEAD ADAPTOR