ENRHYTHM DR
Report
- Report Number
- 2647346-2010-00783
- Event Type
- Death
- Date Received
- December 3, 2010
- Date of Event
- May 10, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DXY
- PMA / PMN Number
- P980035/S38
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
Narratives
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS INFORMATION WAS RECEIVED FROM A COMPETITOR. ALL DATA PERTINENT TO THE EVENT IS PROVIDED. 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.
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS INFORMATION WAS RECEIVED FROM A COMPETITOR. ALL DATA PERTINENT TO THE EVENT IS PROVIDED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY(B)(4). NO ANOMALIES FOUND. (B)(4). NO ANOMALIES FOUND. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4). NO ANOMALIES FOUND, OUTER INSULATION COSMETIC CUT, APPARENT EXPLANT DAMAGE. PROXIMAL SEGMENT RETURNED AND ANALYZED.
ASKU
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THIS INFORMATION WAS RECEIVED FROM A COMPETITOR. ALL DATA PERTINENT TO THE EVENT IS PROVIDED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY (B)(4) NO ANOMALIES FOUND. (B)(4) NO ANOMALIES FOUND. PROXIMAL SEGMENT RETURNED AND ANALYZED. (B)(4) NO ANOMALIES FOUND, OUTER INSULATION COSMETIC CUT, APPARENT EXPLANT DAMAGE. PROXIMAL SEGMENT RETURNED AND ANALYZED.
IT WAS REPORTED THE PATIENT DIED APPROXIMATELY 3 WEEKS AFTER DEVICE IMPLANT. THE CAUSE OF DEATH HAS BEEN REQUESTED AND NOT RECEIVED.
IT WAS REPORTED THE PATIENT DIED APPROXIMATELY 3 WEEKS AFTER DEVICE IMPLANT. PATIENT'S SPOUSE LATER REPORTED PATIENT DIED OF A STROKE AND THERE WAS NO PROBLEM WITH THE DEVICE. PATIENT HAD SLIPPED AND FALLEN IN BATHTUB, HITTING HIS ABDOMEN. PATIENT LATER COMPLAINED OF NAUSEA, "PASSED OUT", AND WAS TAKEN TO THE HOSPITAL WHERE SCANS AND XRAYS REVEALED PATIENT HAD SUFFERED A STROKE. WAS ADMITTED TO THE INTENSIVE CARE UNIT AND DIED 1.5 DAYS LATER. PATIENT HAD HISTORY OF ATRIAL FIBRILLATION AND WAS ON COUMADIN AND SPOUSE REPORTED SHE HAD BEEN TOLD THE COUMADIN PROBABLY CONTRIBUTED TO PATIENT'S BLEEDING IN THE BRAIN. NO AUTOPSY WAS DONE. CLINIC LATER REPORTED PATIENT HAD INCISION AND DEVICE CHECK SEVEN DAYS AFTER IMPLANT AND THE LEADS AND DEVICE CHECKED OUT FINE. THE PATIENT WAS NOT PACER DEPENDENT
ASKU
IT WAS REPORTED THE PATIENT DIED APPROXIMATELY 3 WEEKS AFTER DEVICE IMPLANT. PATIENT'S SPOUSE LATER REPORTED PATIENT DIED OF A STROKE AND THERE WAS NO PROBLEM WITH THE DEVICE. PATIENT HAD SLIPPED AND FALLEN IN BATHTUB, HITTING HIS ABDOMEN. PATIENT LATER COMPLAINED OF NAUSEA, "PASSED OUT", AND WAS TAKEN TO THE HOSPITAL WHERE SCANS AND XRAYS REVEALED PATIENT HAD SUFFERED A STROKE. WAS ADMITTED TO THE INTENSIVE CARE UNIT AND DIED 1.5 DAYS LATER. PATIENT HAD HISTORY OF ATRIAL FIBRILLATION AND WAS ON COUMADIN AND SPOUSE REPORTED SHE HAD BEEN TOLD THE COUMADIN PROBABLY CONTRIBUTED TO PATIENT'S BLEEDING IN THE BRAIN. NO AUTOPSY WAS DONE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENRHYTHM DR | ASKU | DXY | MEDTRONIC MED REL, INC. | P1501DR | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Death| H| L| R |