FDA Adverse Event
Injury
Summary report: N
EVERA S DR
MDR report key: 7500938
·
Received May 9, 2018
Report
- Report Number
- 3004209178-2018-10511
- Event Type
- Injury
- Date Received
- May 9, 2018
- Date of Event
- April 27, 2018
- Report Date
- May 9, 2018
- Manufacturer
- MEDTRONIC PUERTO RICO OPERATIONS CO.
- Product Code
- LWS
- UDI-DI
- 00643169530287
- PMA / PMN Number
- P980016
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THE PATIENT RECEIVED INAPPROPRIATE SHOCKS ONE DAY AFTER IMPLANT AND WHILE HOSPITALIZED DUE TO JUNCTIONAL ECTOPIC TACHYCARDIA WITH A HEART RATE OF 240-280. THE PATIENT WAS TREATED WITH MEDICATION AND WEANED OFF. A MAGNET WAS PLACED OVER THE DEVICE; HOWEVER, IT DID NOT DISENGAGE FROM SHOCKING. FOLLOWING, THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR WAS "TURNED OFF" AND THE PATIENT WAS DISCHARGED HOME. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 343682 | EVERA S DR | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MEDTRONIC PUERTO RICO OPERATIONS CO. | DDBC3D1 | 00643169530287 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 16 YR | Hospitalization| L| R |