FDA Adverse Event
Injury
Summary report: N
INSYNC
MDR report key: 1861531
·
Received October 8, 2010
Report
- Report Number
- 6000094-2010-01861
- Event Type
- Injury
- Date Received
- October 8, 2010
- Date of Event
- July 8, 2010
- Manufacturer
- MEDTRONIC S.A.
- Product Code
- DXY
- PMA / PMN Number
- P010015
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- HEALTH PROFESSIONAL
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 DURING A TRANS-TELEPHONIC MONITOR THE MAGNET RATE WAS 65BPM. THE DEVICE HAD A PARTIAL POWER ON RESET WITH A RATE AND OUTPUT CHANGE. THE DEVICE WAS REPROGRAMMED. 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 | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC S.A. | 8040 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention | 2187 IMPLANTABLE PACING LEAD| 4574 IMPLANTABLE PACING LEAD| 4074 IMPLANTABLE PACING LEAD |