FDA Adverse Event
Injury
Summary report: N
MAXIMO II DR
MDR report key: 2203597
·
Received August 11, 2011
Report
- Report Number
- 6000144-2011-04197
- 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 Location
- SC, US
- Reporter Occupation
- PHYSICIAN
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. EVALUATION SUMMARY: (B)(4) THE DEVICE WAS RETURNED, ANALYZED AND NO ANOMALIES WERE FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING REPLACEMENT OF THE IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) THE NEW ICD WAS UNABLE TO RESCUE THE PATIENT WITH FOUR DIFFERENT ATTEMPTS AT 20J, 30J AND 35J TWICE. EXTERNAL RESCUE WAS REQUIRED. THEREFORE, THE ICD WAS REMOVED AND REPLACED WITH A NEW DEVICE. NO PATIENT COMPLICATIONS HAVE BEEN 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 | 83 YR | Hospitalization| R | 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD |