FDA Adverse Event
Malfunction
Summary report: N
RESTORE EXTENSION
MDR report key: 3130321
·
Received May 24, 2013
Report
- Report Number
- 6000153-2013-00099
- Event Type
- Malfunction
- Date Received
- May 24, 2013
- Date of Event
- May 6, 2013
- Report Date
- May 6, 2013
- Manufacturer
- NEURO - VILLALBA
- Product Code
- LGW
- PMA / PMN Number
- P840001
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Additional Manufacturer Narrative · 1
ANALYSIS OF THE EXTENSION, MODEL # 37081, SN (B)(4), FOUND THE 0,1, 2 CONDUCTORS TO BE BROKEN 1.4CM FROM THE DISTAL END.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
IT WAS REPORTED THAT IMPEDANCES VALUES WERE OVER 40,000 OHMS IN THE OPERATING ROOM BEFORE SUTURING THE PATIENT. THE LEAD WAS TESTED AND THE IMPEDANCE VALUES WERE NORMAL. THE LEAD AND EXTENSION WERE TESTED AND A LOT OF IMPEDANCES WERE OVER 40,000 OHMS. IT WAS NOTED THAT AT FIRST, ONLY ELECTRODES 6 AND 7 WERE OUT-OF-RANGE, ON SECOND TEST, EVERY ELECTRODE WAS OUT-OF-RANGE EXCEPT 0 (AFFECTED ELECTRODES VARIED FROM TEST TO TEST). THE EXTENSION WAS REPLACED. THE PATIENT OUTCOME WAS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 231621 | RESTORE EXTENSION | STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF | LGW | NEURO - VILLALBA | 37081-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |