FDA Adverse Event
Malfunction
Summary report: N
UNKNOWN DBS LEAD
MDR report key: 2983485
·
Received February 28, 2013
Report
- Report Number
- 3007566237-2013-00631
- Event Type
- Malfunction
- Date Received
- February 28, 2013
- Report Date
- February 12, 2013
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Removal / Correction Number
- Z-0184-2009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
(B)(4). "POTENTIAL LEAD DAMAGE ASSOCIATED WITH THE DBS LEAD CAP" (B)(4).
Description of Event or Problem · 1
ADDITIONAL INFORMATION STATED THE PATIENT WAS ABLE TO BE ADEQUATELY PROGRAMMED AND THEY WERE RECEIVING GOOD THERAPY. IT WAS ALSO REPORTED THE SCREW BENT AND BROKE A CONTACT BECAUSE IT WAS DIFFICULT TO REMOVE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HCP EXPERIENCED INTRA-OPERATIVE DIFFICULTY WITH THE LEAD CAP, AND AS A RESULT NO LONGER INTENDED TO USE IT. IT WAS REPORTED THAT THERE WAS NO PATIENT INJURY, AND IT WAS UNKNOWN IF ANY ACTION WAS TAKEN AS A RESULT OF THE EVENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 86563 | UNKNOWN DBS LEAD | STIMULATOR, ELECTRICAL, IMPLANTED, FOR PARKINSONIAN TREMOR | MHY | MEDTRONIC NEUROMODULATION | NEU_UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |