FDA Adverse Event
Malfunction
Summary report: N
INSYNC SENTRY
MDR report key: 1072290
·
Received July 10, 2008
Report
- Report Number
- 6000144-2008-00146
- Event Type
- Malfunction
- Date Received
- July 10, 2008
- Date of Event
- May 28, 2008
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NIK
- PMA / PMN Number
- ASKU
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK
- Reporter Occupation
- INVALID DATA
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: THE DEVICE DID NOT MEET EXPECTED LONGEVITY. ANALYSIS OF THE DEVICE AND INTERNAL COMPONENTS WERE AS EXPECTED FOR A DEVICE AT ERI. WITHOUT THE HISTORY OF THE PROGRAMMED SETTINGS THROUGHOUT ITS SERVICE LIFE, THERE IS NO WAY TO DETERMINE WHY THE LONGEVITY DID NOT MATCH THE PREDICTED MODEL.
Description of Event or Problem · 1
ASKU
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INSYNC SENTRY | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | NIK | MEDTRONIC MED REL, INC. | 7299 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | 4194 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| 5076 IMPLANTABLE PACING LEAD |