FDA Adverse Event
Death
Summary report: N
DBS LEAD (WITH STIMLOC KIT)
MDR report key: 1904264
·
Received November 12, 2010
Report
- Report Number
- 6000153-2010-09376
- Event Type
- Death
- Date Received
- November 12, 2010
- Date of Event
- October 26, 2010
- Report Date
- November 3, 2010
- Manufacturer
- MPROC, VILLALBA
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Adverse Event
- Yes
- Product Problem
- 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
THE PATIENT EXPIRED ON (B)(6) 2010 RESULTING AFTER A LEAD PROCEDURE ON (B)(6) 2010 FROM A BLEED. THE PATIENT HAD BEEN ON BLOOD THINNERS PRIOR TO SURGERY BUT WAS WEANED OFF COUMADIN BEFORE THE PROCEDURE. ONLY A SINGLE LEAD WAS IMPLANTED, NO NEUROSTIMULATOR YET. THE PHYSICIAN CONSIDERED THE DEATH TO BE RELATED TO THE IMPLANT, AS THE BLEED WAS RIGHT AT THE TIP OF THE LEAD. THE LEAD WILL NOT BE REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DBS LEAD (WITH STIMLOC KIT) | MHY | MPROC, VILLALBA | 3389S-40 | V475868 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Death |