FDA Adverse Event
Injury
Summary report: N
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
MDR report key: 6042686
·
Received October 19, 2016
Report
- Report Number
- 2938836-2016-13036
- Event Type
- Injury
- Date Received
- October 19, 2016
- Date of Event
- September 15, 2016
- Report Date
- September 15, 2016
- Manufacturer
- ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE)
- Product Code
- NVY
- PMA / PMN Number
- P950022
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
FRACTURES OF THE INNER COIL FILARS WERE NOTED ADJACENT TO THE INNER COIL TO SHAFT WELD. THIS FRACTURE IS CONSISTENT WITH THE OBSERVATION FROM THE FIELD OF NOISE AND INAPPROPRIATE SHOCK.
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT PATIENT WAS PRESENTED TO THE HOSPITAL UNRELATED TO THIS EVENT WHEN PATIENT REPORTED RECEIVING INAPPROPRIATE SHOCKS. PATIENT WAS ASYMPTOMATIC. UPON DEVICE INTERROGATION, OUT OF RANGE, LEAD NOISE AND OVERSENSING WAS OBSERVED ON THE RVA LEAD. UNDER FLUOROSCOPY AND POST LEAD EXPLANT PROCEDURE LEAD FRACTURE WAS OBSERVED. LEAD WAS EXPLANTED AND A NEW LEAD WAS IMPLANTED. PATIENT WAS STABLE POST PROCEDURE AND DISCHARGED THE FOLLOWING DAY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 690293 | DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR | DEFIBRILLATION LEAD | NVY | ST. JUDE MEDICAL, INC.(CRM-SUNNYVALE) | 7122Q/58 | A000009386 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |