FDA Adverse Event
Malfunction
Summary report: N
INTRINSIC
MDR report key: 1854940
·
Received October 5, 2010
Report
- Report Number
- 6000144-2010-04333
- Event Type
- Malfunction
- Date Received
- October 5, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S041
- Removal / Correction Number
- ASKU
- Report Source
- Manufacturer report
- Reporter Location
- 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.
Description of Event or Problem · 1
THE PATIENT REPORTED THAT THEIR HEART RATE IS LOWER THAN NORMAL IN THE MORNING AFTER THE PATIENT HAS BEEN UP FOR AWHILE. THE PATIENT QUESTIONED IF THIS IS RELATED TO THE IMPLANTED DEFIBRILLATOR. THE PATIENT WILL FOLLOW-UP WITH THE PHYSICIAN. THE DEVICE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTRINSIC | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | LWS | MEDTRONIC MED REL, INC. | 7288 | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Other | 5076 IMPLANTABLE PACING LEAD| 6947 IMPLANTABLE TACHY LEAD |