FDA Adverse Event
Injury
Summary report: N
PROTECTA XT DR
MDR report key: 2201771
·
Received August 11, 2011
Report
- Report Number
- 6000094-2011-01337
- Event Type
- Injury
- Date Received
- August 11, 2011
- Date of Event
- May 9, 2011
- Manufacturer
- MEDTRONIC S.A.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S211
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT POST IMPLANT, THE DEVICE EXHIBITED OVERSENSING. THE DEVICE SENSITIVITY WAS REPROGRAMMED, 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 |
|---|---|---|---|---|---|---|---|
| 1 | PROTECTA XT DR | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | LWS | MEDTRONIC S.A. | D314DRG | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Required Intervention | 6947 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD |