FDA Adverse Event
Malfunction
Summary report: N
INSYNC III
MDR report key: 1925345
·
Received December 14, 2010
Report
- Report Number
- 6000094-2010-02285
- Event Type
- Malfunction
- Date Received
- December 14, 2010
- Date of Event
- September 28, 2010
- 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
- IN, US
- Reporter Occupation
- PHYSICIAN
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 UPON INTERROGATION OF A DEVICE THAT HAD BEEN IMPLANTED THE SAME DAY, THE DEVICE LONGEVITY ESTIMATE WAS REPORTING 2 TO 2.5 YEARS. THE DEVICE IS STILL 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 | 58 YR | Other | (B)(4) COMPETITOR IMPLANTABLE PACING LEAD |