FDA Adverse Event
Injury
Summary report: N
MAXIMO II DR
MDR report key: 1991226
·
Received February 15, 2011
Report
- Report Number
- 6000144-2011-00850
- Event Type
- Injury
- Date Received
- February 15, 2011
- Date of Event
- December 20, 2010
- 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
- WA, 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT WHILE CLOSING THE POCKET AT IMPLANT, OVERSENSING AND NOISE WERE SEE ON THE ATRIAL CHANNEL AND ELECTROGRAM OF THE DEVICE, RESPECTIVELY. THE GROMMET WAS MASSAGED AND MEDICAL ADHESIVE APPLIED. THE DEVICE REMAINS IN USE. NO 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 | 62 YR | Required Intervention | 6935 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD |