FDA Adverse Event
Malfunction
Summary report: N
INSYNC SENTRY
MDR report key: 3993271
·
Received August 8, 2014
Report
- Report Number
- 3004209178-2014-14660
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- June 25, 2014
- Report Date
- June 25, 2014
- Manufacturer
- MEDTRONIC MED REL MEDTRONIC PUERTO RICO
- Product Code
- NIK
- PMA / PMN Number
- P010031
- 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. PRODUCTS: 4194-88 LEAD IMPLANTED: 2005 (B)(6). (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE IS IN ELECTIVE REPLACEMENT INDICATOR (ERI) AND SHOWS QUESTION MARKS IN THE ERI TRIGGER FIELD, INDICATING A DATA CORRUPTION ERROR. THE PATIENT IS INTUBATED AND 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 |
|---|---|---|---|---|---|---|---|
| 469343 | INSYNC SENTRY | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO | NIK | MEDTRONIC MED REL MEDTRONIC PUERTO RICO | 7299 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00073 YR | 0157 LEAD, 4469 LEAD |