FDA Adverse Event
Injury
Summary report: N
INSYNC SENTRY
MDR report key: 1863136
·
Received October 9, 2010
Report
- Report Number
- 6000144-2010-05075
- Event Type
- Injury
- Date Received
- October 9, 2010
- Date of Event
- July 23, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- NIK
- PMA / PMN Number
- P010031/S18
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- MI, 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. ANALYSIS OF THE DEVICE IS IN PROCESS; THE RESULTS WILL BE FORWARDED WHEN AVAILABLE. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED BY THE PATIENT THAT HE HEARD ALERT TONES FROM HIS DEVICE DAILY AND THEN HE HAD NOT HEARD ALERTS FROM HIS DEVICE FOR THREE DAYS. THREE DAYS LATER, HE REPORTED HEARING THE ALERT AGAIN. THE DEVICE HAD HAD REACHED ELECTIVE REPLACEMENT (ERI). THE DEVICE WAS EXPLANTED 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 | 69 YR | Required Intervention | 6949 IMPLANTABLE TACHY LEAD| 4193 IMPLANTABLE PACING LEAD| 5076 IMPLANTABLE PACING LEAD |