FDA Adverse Event
Injury
Summary report: N
INSYNC SENTRY
MDR report key: 1875352
·
Received October 19, 2010
Report
- Report Number
- 6000144-2010-05491
- Event Type
- Injury
- Date Received
- October 19, 2010
- Date of Event
- February 22, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NIK
- PMA / PMN Number
- P010031/S18
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
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: (B)(4) ANALYSIS OF THE DEVICE REVEALED NORMAL BATTERY DEPLETION.
Description of Event or Problem · 1
IT WAS REPORTED TODAY ((B)(6)_2010) THAT THE RRT (RECOMMENDED REPLACEMENT TIME) TRIGGERED FOR LOW DEVICE BATTERY VOLTAGE ON (B)(6)_2010. IT WAS FURTHER REPORTED THAT CAPACITOR FORMATION WAS ATTEMPTED (B)(6)_2010. A CHARGE CIRCUIT DISABLED MESSAGE WAS AMONGST THE 30 PLUS WARNING MESSAGES THAT WERE LISTED TODAY. THE DEVICE WAS REMOVED AND REPLACED. 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 | 79 YR | Required Intervention | 5076 IMPLANTABLE PACING LEAD| 6949 IMPLANTABLE TACHY LEAD| 4194 IMPLANTABLE PACING LEAD |