FDA Adverse Event
Injury
Summary report: N
SUBQ
MDR report key: 2223626
·
Received August 25, 2011
Report
- Report Number
- 2182208-2011-02017
- Event Type
- Injury
- Date Received
- August 25, 2011
- Date of Event
- August 15, 2011
- Manufacturer
- MEDTRONIC, INC.
- Product Code
- LWS
- PMA / PMN Number
- P920015/S021
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS EVENT OCCURRED OUTSIDE THE U.S. 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 SUBCUTANEOUS COIL HAD A DROP IN IMPEDANCE AND A PATIENT ALERT OCCURRED. THE LEAD IS BEING 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 | SUBQ | IMPLANTABLE TACHY LEAD | LWS | MEDTRONIC, INC. | 6996 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 2 YR | Hospitalization| R | D354DRG IMPLANTABLE PACEMAKER/CARDIO/DEFIB |