FDA Adverse Event
Injury
Summary report: N
SPRINT
MDR report key: 1860959
·
Received October 7, 2010
Report
- Report Number
- 2649622-2010-10649
- Event Type
- Injury
- Date Received
- October 7, 2010
- Date of Event
- July 19, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S10
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE US. ALL INFORMATION PROVIDED IS INCLUDED IN THIS REPORT. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PATIENT INFORMATION IS NOT GENERALLY AVAILABLE DUE TO CONFIDENTIALITY CONCERNS. EVALUATION SUMMARY: (B)(4) THE PROXIMAL SEGMENT OF THE LEAD WAS RETURNED AND ANALYZED; NO ANOMALIES WERE FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT AN IMPLANTABLE DEFIBRILLATOR PATIENT ALERT TRIGGERED FOR HIGH IMPEDANCE OF THE LEAD. OVERSENSING AND 1000 FAST VENTRICULAR-VENTRICULAR INTERVALS WERE OBSERVED. THE LEAD WAS REMOVED AND REPLACED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SPRINT | IMPLANTABLE TACHY LEAD | LWS | MEDTRONIC PUERTO RICO, INC. | 6932 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention | 7230CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB |