FDA Adverse Event
Injury
Summary report: N
INSYNC III
MDR report key: 2790600
·
Received October 15, 2012
Report
- Report Number
- 6000094-2012-02241
- Event Type
- Injury
- Date Received
- October 15, 2012
- Manufacturer
- MEDTRONIC S.A.
- Product Code
- DXY
- PMA / PMN Number
- P010015/S005
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER
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 RATE RESPONSE SETTING ON THE DEVICE IS TOO SENSITIVE AND THAT THE UNDERLYING RHYTHM AND HISTOGRAMS SHOW FASTER UPPER RATES. THEREFORE THE RATE RESPONSE UPPER RATE SENSITIVITY AND THRESHOLD ADJUSTED. THE DEVICE 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 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Life Threatening| R | 1388T COMPETITOR IMPLANTABLE TACHY LEAD| 4193 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD |