FDA Adverse Event
Injury
Summary report: N
7229CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB
MDR report key: 1072449
·
Received July 10, 2008
Report
- Report Number
- 2649622-2008-03944
- Event Type
- Injury
- Date Received
- July 10, 2008
- Date of Event
- May 19, 2008
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- LWS
- Removal / Correction Number
- NI
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- HI
- Reporter Occupation
- INVALID DATA
Narratives
Additional Manufacturer Narrative · 1
A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS LATER REPORTED THAT THE PATIENT HAS RECEIVED INAPPROPRIATE SHOCKS FROM THE RIGHT VENTRICULAR (RV) LEAD IN THE PAST DUE TO APPARENT EMI (ELECTROMAGNETIC INTERFERENCE). THE HIGH VOLTAGE PORTION OF THE LEAD REMAINS IN USE. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 7229CX IMPLANTABLE PACEMAKER/CARDIO/DEFIB | DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER | LWS | MEDTRONIC PUERTO RICO, INC. | 6945 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Life Threatening| R |