FDA Adverse Event
Injury
Summary report: N
MAXIMO DR
MDR report key: 1855045
·
Received October 5, 2010
Report
- Report Number
- 6000094-2010-01769
- Event Type
- Injury
- Date Received
- October 5, 2010
- Date of Event
- August 9, 2010
- Manufacturer
- MEDTRONIC S.A.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S37
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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.
Additional Manufacturer Narrative · 1
THE INFORMATION SUBMITTED REFLECTS ALL RELEVANT DATA RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. EVALUATION SUMMARY: (B)(4) THE ACTUAL DEVICE WAS NOT RECEIVED FOR EVALUATION. THE PERFORMANCE DATA COLLECTED FROM THE DEVICE WAS ANALYZED AND REVEALED NO ANOMALIES. IMPEDANCE TRENDS APPEAR STABLE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) DELIVERED INAPPROPRIATE THERAPY INTO A SUPRAVENTRICULAR TACHYCARDIA (SVT) RHYTHM. THE DEVICE REMAINS ACTIVE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAXIMO DR | ASKU | LWS | MEDTRONIC S.A. | 7278 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Other | 4574 IMPLANTABLE PACING LEAD| 6944 IMPLANTABLE TACHY LEAD| 4574 IMPLANTABLE PACING LEAD| 6944 IMPLANTABLE TACHY LEAD |