FDA Adverse Event
Injury
Summary report: N
INSYNC II MARQUIS
MDR report key: 1992616
·
Received February 15, 2011
Report
- Report Number
- 6000094-2011-00331
- Event Type
- Injury
- Date Received
- February 15, 2011
- Manufacturer
- MEDTRONIC S.A.
- Product Code
- NIK
- PMA / PMN Number
- P010031/S005
- Removal / Correction Number
- Z-0604-05
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PATIENT
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. THE DEVICE IS PART OF THE ADVISORY FOR THIS MODEL. EVALUATION SUMMARY: (B)(4): NO ANOMALIES FOUND.
Description of Event or Problem · 1
THE PATIENT REPORTED THAT THE DEVICE WAS "DEFECTIVE" AND THAT IT "KNOCKED ME FLAT ON MY BACK". FOLLOW-UP WITH THE PHYSICIAN'S OFFICE DID NOT YIELD ANY ADDITIONAL RELEVANT INFORMATION. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSYNC II MARQUIS | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | NIK | MEDTRONIC S.A. | 7289 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Hospitalization| R | (B)(4) IMPLANTABLE TACHY LEAD| (B)(4) IMPLANTABLE PACING LEAD| (B)(4) IMPLANTABLE PACING LEAD |