FDA Adverse Event
Injury
Summary report: N
NONE
MDR report key: 2791137
·
Received October 15, 2012
Report
- Report Number
- 2649622-2012-14499
- Event Type
- Injury
- Date Received
- October 15, 2012
- Manufacturer
- MEDTRONIC PUERTO RICO, INC.
- Product Code
- DTB
- PMA / PMN Number
- K850968
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, 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.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING THE DEVICE CHANGEOUT THE BIPOLAR IMPEDANCE WAS HIGH FOR THE CHRONIC RIGHT VENTRICULAR AND ATRIAL LEADS WHEN ATTACHED TO THE NEW DEVICE. IT WAS NOTED THAT THE LEAD CONNECTOR PINS DID NOT MATCH THE CONNECTOR TYPE OF THE DEVICE HEADER. THE PHYSICIAN ELECTED TO USE THE 3.2 MM LEADS IN THE IS-1 HEADER WHICH IS OFF-LABEL USE. BOTH LEADS WERE LEFT IMPLANTED PACING IN UNIPOLAR, AND THE IMPEDANCE, THRESHOLD, AND SENSING FOR BOTH LEADS WERE WITHIN NORMAL LIMITS. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | NONE | IMPLANTABLE PACING LEAD | DTB | MEDTRONIC PUERTO RICO, INC. | 4016 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Hospitalization| R | ADDR01 IMPLANTABLE PULSE GENERATOR |