FDA Adverse Event
Injury
Summary report: N
KINETRA
MDR report key: 1901991
·
Received November 12, 2010
Report
- Report Number
- 9614453-2010-09387
- Event Type
- Injury
- Date Received
- November 12, 2010
- Date of Event
- September 4, 2009
- Report Date
- October 29, 2010
- Manufacturer
- MEDTRONIC EUROPE SARL
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4) .
Description of Event or Problem · 1
RECEIVED INFO REPORTING THE PT HAD HER DEVICE REVISED AND MOVED CLOSER TO THE STERNUM BECAUSE THE INS WAS LOOSE IN THE POCKET. NO FURTHER INFO WAS PROVIDED. ADDITIONAL INFO HAS BEEN REQUESTED AND IF RECEIVED, A FOLLOW UP REPORT WILL BE SENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KINETRA | MHY | MEDTRONIC EUROPE SARL | 7428 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | PROGRAMMER: MODEL 7436, LOT# NFU008670P| LEAD: MODEL 3387, LOT# B0321968K| LOT# NFD648098S| IMPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7428| EXTENSION: MODEL 7482, LOT# NHU071816V| EXPLANTED:| IMPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| EXPLANTED:| EXPLANTED:| EXTENSION: MODEL 7482, LOT# NHU077554V| IMPLANTED:| EXPLANTED:| LEAD: MODEL 3387, LOT# B0321982K |