FDA Adverse Event
Malfunction
Summary report: N
DBS LEAD
MDR report key: 2182355
·
Received July 11, 2011
Report
- Report Number
- 6000153-2011-05290
- Event Type
- Malfunction
- Date Received
- July 11, 2011
- Date of Event
- April 26, 2011
- Report Date
- April 26, 2011
- Manufacturer
- MPROC, VILLALBA
- Product Code
- MHY
- PMA / PMN Number
- P96009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
(B)(4): ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A F/U REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.
Description of Event or Problem · 1
RECEIVED INFO WHICH REPORTED DURING THE IMPLANT THE IMPEDANCE READINGS ON CONTACT 0 APPEARED OUT OF ALIGNMENT WITH THE OTHER CONTACTS. THIS HAPPENED WITH THREE LEADS, THE FOURTH LEAD WAS IMPLANTED. THERE WAS NO PT INJURY AND THE PT RECOVERED WITHOUT SEQUELA. REFER TO MFR REPORT # 6000153201105288 AND MFR REPORT # 6000153201105293 FOR RELATED LEADS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | DBS LEAD | MHY | MPROC, VILLALBA | 3389S-40 | V10299354 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | EXPLANTED:| IMPLANTED:| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3389S-40, LOT# V578773| LEAD: MODEL 3389S-40, LOT# V574965 |