FDA Adverse Event
Injury
Summary report: N
MAXIMO DR
MDR report key: 2131662
·
Received June 16, 2011
Report
- Report Number
- 6000144-2011-03531
- Event Type
- Injury
- Date Received
- June 16, 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
- 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): UPON ANALYSIS, NO ANOMALIES FOUND.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE APPARENTLY MALFUNCTIONED. PREVIOUS FOLLOW UP INDICATED THAT THE PATIENT WANTED THE SYSTEM MOVED FROM AN ABDOMINAL IMPLANT LOCATION TO THE LEFT PECTORAL AREA. THE DEVICE WAS EXPLANTED AND REPLACED. 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 DR | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | LWS | MEDTRONIC MED REL, INC. | 7278 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR | Hospitalization| R | 6947 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD |