FDA Adverse Event
Injury
Summary report: N
SPRINT
MDR report key: 1922946
·
Received December 13, 2010
Report
- Report Number
- 2649622-2010-13141
- Event Type
- Injury
- Date Received
- December 13, 2010
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S13
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- HEALTH PROFESSIONAL
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.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE LEAD INTEGRITY ALERT WAS TRIGGERED DUE TO SHORT INTERVAL COUNTS. IT WAS FURTHER REPORTED THAT THE PATIENT WAS HAVING MULTIPLE PREMATURE VENTRICULAR CONTRACTIONS AND THAT THERE WERE FOUR EVENTS OF NON-SUSTAINED TACHYCARDIA RECORDED. DURING ONE OF THESE EVENTS A RUN OF PREMATURE VENTRICULAR CONTRACTIONS (PVCS) WAS NOTED, AND THE PATIENT EXPERIENCED SYNCOPE. THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN RECORDED 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. | 6945 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Other| R | (B)(4) VALVE| (B)(4) IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACEMAKER/CARDIO/DEFIB |