FDA Adverse Event
Malfunction
Summary report: N
INSYNC III
MDR report key: 1924606
·
Received December 14, 2010
Report
- Report Number
- 6000094-2010-02279
- Event Type
- Malfunction
- Date Received
- December 14, 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
- CA, 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 THE PATIENT WAS GETTING DIAPHRAM STIM AND SAYS HIS HEART RATE INCREASES VERY QUICKLY WITH LITTLE ACTIVITY. RATE RESPONSE AND STIM CONCERNS WERE DISCUSSED WITH THE PATIENT AND PATIENT WAS REFERRED TO PHYSICIAN. THE DEVICE REMAINS IN USE. NO 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 | 63 YR | Other | 4076 X2 IMPLANTABLE PACING LEAD| 4195 IMPLANTABLE PACING LEAD |