FDA Adverse Event
Injury
Summary report: N
INSYNC MAXIMO
MDR report key: 1792427
·
Received August 11, 2010
Report
- Report Number
- 6000144-2010-03250
- Event Type
- Injury
- Date Received
- August 11, 2010
- Date of Event
- May 6, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NIK
- PMA / PMN Number
- P010031/S18
- Removal / Correction Number
- ASKU
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PATIENT FAMILY MEMBER OR FRIEND
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
THE PATIENT'S WIFE REPORTED THAT THE ICD WAS BEING REPLACED BECAUSE THE "BATTERY IS RUNNING OUT." SHE ALSO STATED THAT THE PATIENT WAS HAVING BREATHING PROBLEMS AND FLUID BUILD-UP, AND THINKS THAT IT IS RELATED TO THE ICD. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AT A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSYNC MAXIMO | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | NIK | MEDTRONIC MED REL, INC. | 7304 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Other | 4194 IMPLANTABLE PACING LEAD| 4058M IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD |