FDA Adverse Event
Injury
Summary report: N
INSYNC SENTRY
MDR report key: 1802833
·
Received August 17, 2010
Report
- Report Number
- 6000144-2010-04212
- Event Type
- Injury
- Date Received
- August 17, 2010
- Date of Event
- June 14, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NIK
- PMA / PMN Number
- P010031/S18
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT PRESENTED TO THE EMERGENCY ROOM WITH INAPPROPRIATE SHOCKS FOR T-WAVE OVERSENSING. AN ADJUSTMENT WAS MADE TO THE RIGHT VENTRICULAR (RV) SENSITIVITY WAS ADJUSTED. HOWEVER, AS THE CRT-D WAS AT ELECTRIC REPLACEMENT INDICATOR STATUS, THE PHYSICIAN OPTED TO PLACE THE CRT-D. ADDITIONALLY, THE PHYSICIAN DECIDED TO ADD A NEW PACE/SENSE LEAD TO ALLEVIATE ANY SUSPICION THAT THE PROBLEM THAT COULD BE DUE TO THE RIGHT VENTRICULAR LEAD. 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 SENTRY | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | NIK | MEDTRONIC MED REL, INC. | 7299 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Required Intervention | 5076 IMPLANTABLE PACING LEAD| 4194 IMPLANTABLE PACING LEAD |