SPRINT
Report
- Report Number
- 2182208-2011-00943
- Event Type
- Malfunction
- Date Received
- June 16, 2011
- Date of Event
- October 11, 2010
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S13
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4): THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. PROGRAMMER DATA SHOWS A LEAD INTEGRITY ALERT ON (B)(6) 2009 22:03:15. ONE - PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(6) 2009 22:03:15. FOURTEEN - VENTRICULAR NST (NON-SUSTAINED TACHYCARDIA) <=210 MS AVERAGE V-CYCLE BETWEEN (B)(6) 2011 11:23:53 AND (B)(6) 2011 00:04:49. WEEKLY PACING IMPEDANCE TREND DATA SHOWS VARYING IMPEDANCE FOR MIN AND MAX ATRIAL PACE=400 TO 1016 OHMS RANGE BETWEEN (B)(6) 2009 AND (B)(6) 2011.
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) AND (B)(4): THE ACTUAL LEAD WAS NOT RECEIVED FOR EVALUATION. WE DID RECEIVE PERFORMANCE DATA COLLECTED FROM THE DEVICE AND HAVE ANALYZED THE DATA. PROGRAMMER DATA SHOWS A LEAD INTEGRITY ALERT ON (B)(4) 2009 22:03:15. ONE - PATIENT ALERT FOR OUT OF TOLERANCE SUBTHRESHOLD LEAD IMPEDANCE ON (B)(4) 2009 22:03:15. FOURTEEN (14) - VENTRICULAR NST (NON-SUSTAINED TACHYCARDIA) <=210 MS AVERAGE V-CYCLE BETWEEN (B)(4) 2011 11:23:53 AND (B)(4) 2011 00:04:49. WEEKLY PACING IMPEDANCE TREND DATA SHOWS VARYING IMPEDANCE FOR MIN AND MAX ATRIAL PACE=400 TO 1016 OHMS RANGE BETWEEN (B)(4) 2009 AND (B)(4) 2011.
IT WAS REPORTED THAT A LEAD INTEGRITY ALERT WAS TRIGGERED, THERE WERE EPISODES OF NON-SUSTAINED TACHYCARDIA AND OVERSENSING ON THE ATRIAL AND VENTRICULAR CHANNELS. IT WAS ALSO REPORTED THAT THERE WAS VARIATION IN IMPEDANCE ON THE ATRIAL LEAD. LOOSE SETSCREWS AND/OR LEAD FRACTURES SUSPECTED. NO INTERVENTION REPORTED. THE LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT A LEAD INTEGRITY ALERT WAS TRIGGERED, THERE WERE EPISODES OF NON-SUSTAINED TACHYCARDIA AND OVERSENSING ON THE ATRIAL AND VENTRICULAR CHANNELS. IT WAS ALSO REPORTED THAT THERE WAS VARIATION IN IMPEDANCE ON THE ATRIAL LEAD. LOOSE SETSCREWS AND/OR LEAD FRACTURES SUSPECTED. NO INTERVENTION REPORTED. THE LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
IT WAS REPORTED THAT A LEAD INTEGRITY ALERT WAS TRIGGERED, THERE WERE EPISODES OF NON-SUSTAINED TACHYCARDIA AND OVERSENSING ON THE ATRIAL AND VENTRICULAR CHANNELS. IT WAS ALSO REPORTED THAT THERE WAS VARIATION IN IMPEDANCE ON THE ATRIAL LEAD. LOOSE SETSCREWS AND/OR LEAD FRACTURES SUSPECTED. NO INTERVENTION REPORTED. THE LEADS REMAIN IN USE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. IT WAS FURTHER REPORTED THAT THERE WAS BLOOD IN THE INSULATION OF THE RV (RIGHT VENTRICULAR) TACHY LEAD. THE PACE/SENSE PORTION OF THE LEAD WAS CAPPED, A NEW PACE/SENSE LEAD WAS IMPLANTED, AND THE DEFIBRILLATION PORTION REMAINS IN USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPRINT | IMPLANTABLE TACHY LEAD | LWS | MEDTRONIC, INC. | 6945 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Other | D154ATG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| D154ATG IMPLANTABLE PACEMAKER/CARDIO/DEFIB| D153ATG IMPLANTABLE PACEMAKER/CARDIO/DEFIB |