FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN LEAD
MDR report key: 2822884
·
Received November 7, 2012
Report
- Report Number
- 3007566237-2012-02647
- Event Type
- Malfunction
- Date Received
- November 7, 2012
- Date of Event
- October 9, 2012
- Report Date
- October 9, 2012
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PRODUCT ID M924256A001, IMPLANTED: 2012-(B)(6), PRODUCT TYPE ACCESSORY. (B)(4).
Description of Event or Problem · 1
IT WAS REPORTED THE SUPPORT CLIP DID NOT STAY IN PLACE WHEN THE SURGEON TRIED TO PUT THE BURR HOLE COVER ON. THE MOVEMENT OF THE SUPPORT CLIP INDUCED A CHANGE OF LEAD POSITION. THE SURGEON HAD TO REMOVE THE LEAD AND REPOSITION IT. THE PHYSICIAN MANAGED TO PUT THE LEAD IN THE TARGETED SPOT. THE PATIENT WAS 'OKAY.'
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN LEAD | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC NEUROMODULATION | NEU_UNKNOWN_LEAD |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |