FDA Adverse Event
Injury
Summary report: N
INSYNC SENTRY
MDR report key: 1013412
·
Received March 10, 2008
Report
- Report Number
- 6000144-2008-00048
- Event Type
- Injury
- Date Received
- March 10, 2008
- Date of Event
- November 8, 2007
- 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
- MS, 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. EVALUATION SUMMARY: BATTERY DEPLETION WAS NORMAL.
Description of Event or Problem · 1
THE PATIENT REPORTED THAT THE "BATTERIES AREN'T LASTING VERY LONG." THE DEVICE WAS EXPLANTED AND REPLACED. IT WAS SUBSEQUENTLY RETURNED WITH REPORT OF ERI (ELECTIVE REPLACEMENT INDICATORS). NO PATIENT COMPLICATIONS HAVE BEEN 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 | 83 YR | Required Intervention | 6949 IMPLANTABLE TACHY LEAD| 4193 IMPLANTABLE PACING LEAD |