FDA Adverse Event
Injury
Summary report: N
SPRINT
MDR report key: 3991390
·
Received August 8, 2014
Report
- Report Number
- 2182208-2014-02149
- Event Type
- Injury
- Date Received
- August 8, 2014
- Date of Event
- May 23, 2014
- Report Date
- May 23, 2014
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015
- 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. CONCOMITANT PRODUCT: 507652 LEAD IMPLANTED: (B)(6) 2014. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THAT THE PATIENT PRESENTED AFTER HEARING AN ALARM. IT WAS DETERMINED THAT THE RIGHT VENTRICULAR (RV) AND SUPERIOR VENA CAVA (SVC) COIL IMPEDANCES WERE ELEVATED DUE TO A POSSIBLE FRACTURE. THE RV LEAD WAS EXPLANTED AND REPLACED SUCCESSFULLY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 469669 | SPRINT | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MEDTRONIC, INC. | 6945 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00065 YR | Hospitalization| R | DDBB1D1 ICD |