FDA Adverse Event
Injury
Summary report: N
ENTRUST AT
MDR report key: 1925217
·
Received December 14, 2010
Report
- Report Number
- 6000144-2010-06242
- Event Type
- Injury
- Date Received
- December 14, 2010
- Date of Event
- September 23, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S46
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, 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 DURING DEVICE INTERROGATION IN THE EMERGENCY ROOM, IT WAS NOTICED THAT THERE WAS ONLY ONE THERAPY PROGRAMMED ON FOR THE TREATMENT OF VENTRICULAR FIBRILLATION. ACCORDING TO THE MANUFACTURER'S DEVICE IMPLANT DATABASE, THE DEVICE WAS SUBSEQUENTLY EXPLANTED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENTRUST AT | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | LWS | MEDTRONIC MED REL, INC. | D154ATG | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Hospitalization| L| R | 5092 IMPLANTABLE PACING LEAD| 6948 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD |