FDA Adverse Event
Malfunction
Summary report: N
INSYNC III
MDR report key: 2053189
·
Received April 13, 2011
Report
- Report Number
- 6000094-2011-00529
- Event Type
- Malfunction
- Date Received
- April 13, 2011
- Manufacturer
- MEDTRONIC S.A.
- Product Code
- DXY
- PMA / PMN Number
- P010015/S005
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PATIENT
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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT STATED THE "CLINIC TOLD HIM THE PACEMAKER WAS MISSING A LEAD OR NOT PICKING IT UP." IT WAS ALSO REPORTED THAT THE PATIENT HAS LOST CONFIDENCE IN THE DOCTOR AND IS SEEKING A NEW DOCTOR. THE PACEMAKER REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSYNC III | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC S.A. | 8042 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Other | 5076 X2 IMPLANTABLE PACING LEAD| 1056T COMPETITOR IMPLANTABLE PACING LEAD |