FDA Adverse Event
Injury
Summary report: N
MAXIMO II DR
MDR report key: 2203549
·
Received August 11, 2011
Report
- Report Number
- 6000144-2011-04340
- Event Type
- Injury
- Date Received
- August 11, 2011
- Date of Event
- May 26, 2011
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S114
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- 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 FOR (B)(4): THE DEVICE WAS RETURNED AND ANALYZED AND NO ANOMALIES WERE FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING IMPLANT THE DEVICE DID DETECT THE ARRHYTHMIA, BUT DID NOT DELIVER A DEFIBRILLATION SHOCK ALTHOUGH THE EPISODE WAS STILL ONGOING. THE PATIENT WAS EXTERNALLY DEFIBRILLATED. THE DEVICE WAS REMOVED AND REPLACED. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MAXIMO II DR | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | LWS | MEDTRONIC MED REL, INC. | D284DRG | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Life Threatening| R |