FDA Adverse Event
Injury
Summary report: N
MAXIMO DR
MDR report key: 2053281
·
Received April 13, 2011
Report
- Report Number
- 6000144-2011-01613
- Event Type
- Injury
- Date Received
- April 13, 2011
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S37
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, 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 PATIENT'S CARELINK TRANSMISSION SHOWED "ODD" ELECTROGRAMS. THE DEFIBRILLATOR WAS REMOVED AND REPLACED. 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 | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | LWS | MEDTRONIC MED REL, INC. | 7278 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Hospitalization| R | 6949 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD |