FDA Adverse Event
Injury
Summary report: N
INSYNC SENTRY
MDR report key: 1072323
·
Received July 10, 2008
Report
- Report Number
- 6000144-2008-00172
- Event Type
- Injury
- Date Received
- July 10, 2008
- Date of Event
- May 9, 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 Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
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: BATTERY DEPLETION-NORMAL.
Description of Event or Problem · 1
IT WAS REPORTED BY THE MANUFACTURER'S REPRESENTATIVE THAT THE DEVICE WAS REPLACED DUE TO PREMATURE BATTERY DEPLETION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
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 | 6949 IMPLANTABLE TACHY LEAD| 4194 IMPLANTABLE PACING LEAD |