SPRINT QUATTRO SECURE
Report
- Report Number
- 2649622-2010-08878
- Event Type
- Death
- Date Received
- August 25, 2010
- Date of Event
- June 13, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S24
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND, THE PROXIMAL CONDUCTOR WAS DISTORTED, ALL CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED) PRESENT, OUTER INSULATION WAS MELTED, THE OUTER INSULATION WAS BREACHED/CUT, AND THE LEAD EXHIBITED APPARENT EXPLANT DAMAGE. THE FULL LEAD WAS RETURNED AND ANALYZED. PARTIAL LEAD IN SEGMENTS RETURNED AND ANALYZED. BLOOD IN/ON HELIX/LOBE MECHANISM (SLEEVE HEAD). FULL LEAD RETURNED AND ANALYZED. AT THE TIME OF THE RETRO REVIEW, IT WAS NOTED IN THE MANUFACTURER'S DATABASE THAT THE PATIENT HAD DIED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED.
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. AT THE TIME OF THE RETRO REVIEW, IT WAS NOTED IN THE MANUFACTURER'S DATABASE THAT THE PATIENT HAD DIED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND, THE PROXIMAL CONDUCTOR WAS DISTORTED, ALL CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED) PRESENT, OUTER INSULATION WAS MELTED, THE OUTER INSULATION WAS BREACHED/CUT, AND THE LEAD EXHIBITED APPARENT EXPLANT DAMAGE. THE FULL LEAD LEAD WAS RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND. (B)(4) NO ANOMALIES FOUND. PARTIAL LEAD IN SEGMENTS RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND, BLOOD IN/ON HELIX/LOBE MECHANISM (SLEEVE HEAD). FULL LEAD RETURNED AND ANALYZED. CORRECTION - DEVICE CONCLUSION CODE ON SN (B)(4) .
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) NO ANOMALIES FOUND, THE PROXIMAL CONDUCTOR WAS DISTORTED, ALL CONDUCTORS HAD BLOOD/BODY FLUID (NOT OBSTRUCTED) PRESENT, OUTER INSULATION WAS MELTED, THE OUTER INSULATION WAS BREACHED/CUT, AND THE LEAD EXHIBITED APPARENT EXPLANT DAMAGE. THE FULL LEAD WAS RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND. (B)(4) NO ANOMALIES FOUND. PARTIAL LEAD IN SEGMENTS RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND, BLOOD IN/ON HELIX/LOBE MECHANISM (SLEEVE HEAD). FULL LEAD RETURNED AND ANALYZED. AT THE TIME OF THE RETRO REVIEW, IT WAS NOTED IN THE MANUFACTURER'S DATABASE THAT THE PATIENT HAD DIED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
IT WAS REPORTED THAT THE PATIENT HOSPITALIZED FOR INFECTION ON (B)(6)2008 AND THE ENTIRE SYSTEM WAS EXPLANTED AND NOT REPLACED ON (B)(6)2008. IT WAS FURTHER NOTED THAT THE LEFT VENTRICULAR LEAD HAD DISLODGED AND HAD UNACCEPTABLE THRESHOLDS PRIOR TO BEING EXPLANTED FOR INFECTION. LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT EXPIRED. FOLLOW UP NOTED THE PATIENT WAS FOUND DOWN AT HOME AND WHEN EMS ARRIVED, PATIENT WITHOUT PULSE OR RESPIRATIONS. CAUSE OF DEATH WAS REPORTED TO BE CARDIAC ARREST.
IT WAS REPORTED THAT THE PATIENT HOSPITALIZED ON (B)(6) 2008 AFTER A FALL AT WHICH TIME ELEVATED TROPONIN LEVELS WERE FOUND WITH A DIAGNOSIS OF MYOCARDIAL INFARCTION. ON (B)(6) 2008 THE PATIENT WAS ALSO DIAGNOSED WITH ENDOCARDITIS AND HAD POSITIVE BLOOD CULTURES. AN ECHOCARDIAGRAM SHOWED NO VEGETATION ON DEVICE LEADS. THE ENTIRE SYSTEM WAS EXPLANTED AND NOT REPLACED ON (B)(6) 2008. IT WAS FURTHER NOTED THAT THE LEFT VENTICULAR LEAD HAD DISLODGED AND HAD UNACCEPTABLE THRESHOLDS PRIOR TO BEING EXPLANTED FOR INFECTION. THE PATIENT CONTINUED ANTIBIOTIC THERARPY AND WAS RELEASED FROM HOSPITAL. THE PATIENT WAS FOUND ON (B)(6) 2008. EMS ARRIVED AND ADMINISTERED MULTIPLE EXTERNAL SHOCKS FOR RHYTHMS OF VENTRICULAR FIBRILLATION. THE ICD/PACEMAKER DEVICE WAS NO LONGER IN PATIENT AND HAD BEEN REMOVED FOR ONE MONTH AT THE TIME OF DEATH. CAUSE OF DEATH WAS REPORTED TO BE CARDIAC ARREST.
IT WAS REPORTED PATIENT HOSPITALIZED ON (B)(6) 2008 AFTER FALL WHEN ELEVATED TROPONIN LEVELS WERE FOUND WITH DIAGNOSIS OF MYOCARDIAL INFARCTION. ON (B)(6) 2008 PATIENT DIAGNOSED WITH ENDOCARDITIS WITH POSITIVE BLOOD CULTURES. ECHOCARDIAGRAM SHOWED NO VEGETATION ON LEADS. ENTIRE SYSTEM EXPLANTED AND NOT REPLACED ON (B)(6) 2008. FURTHER NOTED LEFT VENTICULAR LEAD DISLODGED AND HAD UNACCEPTABLE THRESHOLDS PRIOR TO EXPLANT FOR INFECTION. PATIENT CONTINUED ANTIBIOTIC THERARPY AND RELEASED FROM HOSPITAL. PATIENT WAS FOUND DOWN ON (B)(6) 2008. EMS ARRIVED AND ADMINISTERED MULTIPLE EXTERNAL SHOCKS FOR RHYTHMS OF VENTRICULAR FIBRILLATION. DEVICE WAS NO LONGER IN PATIENT AS HAD BEEN REMOVED ONE MONTH PRIOR. CAUSE OF DEATH WAS REPORTED TO BE CARDIAC ARREST. LATER REPORTED RV LEAD PACING THRESHOLD HAD ALSO INCREASED SUBSTANTIALLY AT 3 MONTHS AFTER IMPLANT, BUT PATIENT WAS "SO BORDERLINE AND PRECARIOUS," AND SINCE THE LEAD WAS WORKING, LEAD NOT REVISED AT THAT TIME.
IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION AND THE ENTIRE SYSTEM WAS EXPLANTED AND NOT REPLACED. IT WAS FURTHER NOTED THAT THE LEFT VENTICULAR LEAD HAD DISLODGED AND HAD UNACCEPTABLE THRESHOLDS PRIOR TO BEING EXPLANTED. LATER REVIEW OF MANUFACTURER'S DATABASE REVEALED THE PATIENT EXPIRED. THERE IS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE RELATED. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPRINT QUATTRO SECURE | ASKU | LWS | MEDTRONIC PUERTO RICO, INC. | 6947 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Death| H| L| R |