FDA Adverse Event
Malfunction
Summary report: N
SYNCRA CRT-P
MDR report key: 2203173
·
Received August 11, 2011
Report
- Report Number
- 2182208-2011-01229
- Event Type
- Malfunction
- Date Received
- August 11, 2011
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- NVZ
- PMA / PMN Number
- P010015/S084
- Removal / Correction Number
- ASKU
- 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 DOCTORS CONCERNED ABOUT THE DEVICE'S ROUGH OUTER SURFACE OVER THE ELECTRODES. IN THE SILICONE VERY SMALL HOLES ARE SEEN WHICH ADD TO THE 'ROUGH" FEEL TO THE SURFACE. ONE DOCTOR COMPLAINED THAT THE SILICONE ITSELF IS ROUGH AND HAS NOTED EXCESS BITS OR STRINGS ON THE EDGE OF THE CAN. 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 | SYNCRA CRT-P | IMPLANTABLE PULSE GENERATOR | NVZ | MEDTRONIC, INC. | C2TR01 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |