FDA Adverse Event
Injury
Summary report: N
PROTECTA DR
MDR report key: 2810931
·
Received October 31, 2012
Report
- Report Number
- 6000144-2012-05938
- Event Type
- Injury
- Date Received
- October 31, 2012
- Date of Event
- September 7, 2012
- Manufacturer
- MEDTRONIC MED REL, INC.
- Product Code
- LWS
- PMA / PMN Number
- P980016/S218
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, 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 THE DAY FOLLOWING IMPLANT, THE PATIENT'S VENTRICULAR PACING IMPEDANCE WAS HIGH AND THERE WAS NO CAPTURE AT MAXIMUM OUTPUTS. A CONNECTION ISSUE WAS SUSPECTED. THE POCKET WAS REOPENED AND WHEN THE PHYSICIAN TUGGED ON THE LEAD IT PULLED FREE. THE LEAD WAS RECONNECTED TO THE DEVICE WRENCHED DOWN AND NORMAL FUNCTION WAS SEEN. THE LEAD AND DEVICE REMAIN 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 | PROTECTA DR | IMPLANTABLE PACEMAKER/CARDIO/DEFIB | LWS | MEDTRONIC MED REL, INC. | D334DRM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Hospitalization| R | 4076 IMPLANTABLE PACING LEAD |