FDA Adverse Event
Malfunction
Summary report: N
EXTERNAL NEUROSTIMULATOR
MDR report key: 1893245
·
Received November 3, 2010
Report
- Report Number
- 3007566237-2010-08807
- Event Type
- Malfunction
- Date Received
- November 3, 2010
- Date of Event
- January 1, 2010
- Report Date
- October 12, 2010
- Manufacturer
- MEDTRONIC NEUROMODULATION
- Product Code
- LGW
- PMA / PMN Number
- P840001
- 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
IT WAS REPORTED THAT DURING A TRIAL, ONE OF THE 1X8 LEADS HAD NO RESPONSE. THE LEAD WAS INSERTED INTO THE OTHER CONNECTION BLOCK WITH NO RESPONSE AGAIN. ALL IMPEDANCES WERE HIGH. THE LEAD WAS REPLACED AND THE PT EXPERIENCED GOOD STIMULATION. PROGRAMS WERE PROVIDED THAT ACHIEVED THE COVERAGE NEEDED. ADDITIONAL INFO HAS BEEN REQUESTED, A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFO BECOMES AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EXTERNAL NEUROSTIMULATOR | LGW | MEDTRONIC NEUROMODULATION | 37021 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | IMPLANTED:| LEAD: MODEL 3778, LOT # V261528019| LEAD: MODEL 3778, LOT # V262576021| EXPLANTED:| EXPLANTED:| IMPLANTED: |