FDA Adverse Event
Malfunction
Summary report: N
SIGMA 300 SR
MDR report key: 1865020
·
Received October 12, 2010
Report
- Report Number
- 6000094-2010-01979
- Event Type
- Malfunction
- Date Received
- October 12, 2010
- Date of Event
- July 30, 2010
- Manufacturer
- MEDTRONIC S.A.
- Product Code
- DXY
- PMA / PMN Number
- P980035/S2
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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 AN IMPLANTABLE PACEMAKER COULD NOT BE INTERROGATED AND THE PACEMAKER DID NOT RESPOND TO AN APPLICATIION OF A MAGNET. 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 | SIGMA 300 SR | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC S.A. | SSR303 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR | Other | 4092 IMPLANTABLE PACING LEAD |