FDA Adverse Event
Injury
Summary report: N
THERA-I DR
MDR report key: 1874676
·
Received October 19, 2010
Report
- Report Number
- 2647346-2010-00652
- Event Type
- Injury
- Date Received
- October 19, 2010
- Date of Event
- August 27, 2010
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- DXY
- PMA / PMN Number
- P890003/S37
- Removal / Correction Number
- ASKU
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, 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) DEVICE ANALYSIS FOUND NORMAL BATTERY DEPLETION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS NOT ABLE TO BE INTERROGATED AND NO PACING WAS SEEN WHEN THE PATIENT ARRIVED IN THE EMERGENCY ROOM. THE PATIENT HAD BEEN LOST TO FOLLOW UP. THE DEVICE WAS REPLACED. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | THERA-I DR | IMPLANTABLE PULSE GENERATOR | DXY | MEDTRONIC MED REL, INC. | 7960IU | ASKU |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Required Intervention | 5024M IMPLANTABLE PACING LEAD| 4524 IMPLANTABLE PACING LEAD |