MAXIMO II VR
Report
- Report Number
- 2647346-2011-00182
- Event Type
- Death
- Date Received
- February 15, 2011
- Date of Event
- September 7, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S114
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VT, US
- Reporter Occupation
- RISK MANAGER
Narratives
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE LEAD IS PART OF THE ADVISORY FOR THIS MODEL. ANALYSIS OF THE LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY (B)(4): THE DEVICE WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS 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. THE LEAD IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY (B)(4): THE DEVICE WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. (B)(4): THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. IT WAS NOTED THERE WAS OUTER INSULATION COSMETIC DEPRESSION AND VISUAL ANALYSIS WAS PERFORMED ONLY. THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS 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. THE LEAD IS PART OF THE ADVISORY FOR THIS MODEL. ANALYSIS OF THE LEAD IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. EVALUATION SUMMARY (B)(4): THE DEVICE WAS RETURNED AND ANALYZED. NO ANOMALIES WERE FOUND. THIS REPORT IS BASED SOLELY ON DEVICE RETURN AND ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE-RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
IT WAS REPORTED THE PATIENT DIED APPROXIMATELY FOUR MONTHS FROM SYSTEM IMPLANT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. BASED ON FOLLOW-UP RECEIVED FROM THE CLINIC, THE PATIENT WAS LAST SEEN IN THE CLINIC APPROXIMATELY EIGHT DAYS PRIOR TO DEATH. THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH CHRONIC HEART FAILURE AND DIED WITH SEVERE HEART FAILURE, PULMONARY HYPERTENSION, AND RIGHT SIDED PLEURAL EFFUSION. THE PRIMARY CAUSE OF DEATH IS CHRONIC HEART FAILURE. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED AND THERE WAS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE OR LEAD RELATED.
IT WAS REPORTED THE PATIENT DIED APPROXIMATELY FOUR MONTHS FROM SYSTEM IMPLANT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.
IT WAS REPORTED THE PATIENT DIED APPROXIMATELY FOUR MONTHS FROM SYSTEM IMPLANT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED. BASED ON FOLLOW-UP RECEIVED FROM THE CLINIC, THE PATIENT WAS LAST SEEN IN THE CLINIC APPROXIMATELY EIGHT DAYS PRIOR TO DEATH. THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH CHRONIC HEART FAILURE AND DIED WITH SEVERE HEART FAILURE, PULMONARY HYPERTENSION, AND RIGHT SIDED PLEURAL EFFUSION. THE PRIMARY CAUSE OF DEATH IS CHRONIC HEART FAILURE. IT IS UNKNOWN IF AN AUTOPSY WAS PERFORMED AND THERE WAS NO ALLEGATION FROM A HEALTH CARE PROFESSIONAL THAT THE DEATH WAS DEVICE OR LEAD RELATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAXIMO II VR | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | LWS | MEDTRONIC MED REL, INC. | D284VRC | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Death| H |