FDA Adverse Event
Malfunction
Summary report: N
1X8 TEST STIMULATION LEAD
MDR report key: 1926034
·
Received November 10, 2010
Report
- Report Number
- 6000153-2010-09218
- Event Type
- Malfunction
- Date Received
- November 10, 2010
- Date of Event
- October 22, 2010
- Report Date
- October 22, 2010
- Manufacturer
- MPROC, VILLALBA
- Product Code
- GZB
- 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). THE LEAD HAS BEEN RETURNED TO THE MANUFACTURER FOR ANALYSIS. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE TIP OF THE LEAD WAS BENT WHEN IT WAS REMOVED FROM STERILE PACKAGING. THE LEAD WAS NOT IMPLANTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 1X8 TEST STIMULATION LEAD | GZB | MPROC, VILLALBA | 3873 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | IMPLANTED:| EXPLANTED:| STIM ACCESSORY: MODEL STYLET/RESTORE, LOT# UNK |