| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | INTERFACE 8252800 RESPONSE 2.0 INCREMENT | ELECTROMYOGRAPH, DIAGNOSTIC | MEDTRONIC XOMED, INC. | IKN | 8252800 | 8252800 | 42922800 | Y | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2013-08-06 | 0 |
Patient 1
IT WAS REPORTED INTRAOPERATIVELY THAT ONE UNKNOWN CHANNEL WAS NOT WORKING. THE FACILITY WAS UNABLE TO DUPLICATE THE PROBLEM AND ALL CHANNELS FUNCTIONED NORMALLY WHEN TESTED WITH THE PATIENT SIMULATOR. THE EXPIRATION DATES OF ALL THE ELECTRODES WERE CHECKED AND CONFIRMED TO BE OK. THERE WAS NO REPORT OF PATIENT IMPACT OR INJURY AS A RESULT OF THE EVENT.
Patient 1
CONCOMITANT PRODUCTS: MAINFRAME RESPONSE 2.0 W/INCREMENTING PROBE (8252001IP); SN: (B)(4); LOT: 43125900; MANUFACTURED: FEBRUARY 28, 2006; RETURNED TO MEDTRONIC: (B)(4) 2013 (2) PROBE NIM MUTING DETECTOR (8220300); SN: NOT PROVIDED; LOT: 43146900; MANUFACTURED: UNAVAILABLE; NOT RETURNED TO MEDTRONIC. (B)(4). IN RESPONSE TO MEDTRONIC?S REQUEST FOR DEVICE RETURN, ONLY THE NIM RESPONSE 2.0 MAINFRAME WITH INCREMENTING PROBE WAS RETURNED FOR EVALUATION. QUALITY ENGINEERING COULD NOT DUPLICATE OR CONFIRM THE ALLEGED COMPLAINT, FINDING NO FAULT WITH THE DEVICE RELATED TO THE REPORTED ?CHANNEL NOT WORKING.? HOWEVER, THE CPU BATTERY WAS OUT OF SPECIFICATION AND THE TOUCHSCREEN WOULD NOT CALIBRATE. BOTH ITEMS WERE REPLACED; THE DEVICE WAS TESTED TO SPECIFICATIONS AND RETURNED TO THE CUSTOMER. A TOTAL OF TWO OF THE THREE DEVICES WERE NOT RETURNED AND THEREFORE EVALUATION COULD ONLY BE PERFORMED ON ONE DEVICE. THE FOLLOWING CODES WERE NOT AVAILABLE IN MEDTRONIC'S GCH SYSTEM: METHOD: NO TESTING METHODS PERFORMED, (B)(4). THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES.
Patient 1
CONCOMITANT MEDICAL PRODUCTS: DEVICES (8252800 AND 8220300) WERE RETURNED TO MEDTRONIC FOR EVALUATION ON AUGUST 21, 2013. THE TWO REMAINING UNRETURNED DEVICES WERE FINALLY RECEIVED FOR EVALUATION. DETAILS OF THE ANALYSIS FINDINGS ARE AS FOLLOWS: 8252800 (QUANTITY 1) - THE PATIENT INTERFACE CAME IN WORKING BUT WHEN TESTING WITH THE PATIENT SIMULATOR AND UPON CONTACT WITH A SIMULATED NERVE, THE CHANNEL GOES IN AND OUT. THE PATIENT INTERFACE CABLE WAS REMOVED AND ONE OF THE STIMULATION CABLES WAS FOUND TO BE LOOSE. THE TOP HOUSING ALSO WOULD NOT LOCK DOWN WITH THE SCREWS. THE PC BOARD, CABLE AND TOP HOUSING WERE ALL REPLACED. 8220300 (QUANTITY 1) - THE DEVICE WAS RECEIVED WITH A CUT IN THE CABLE AND A MISSING O-RING. THE CABLE AND O-RING WERE BOTH REPLACED. BOTH DEVICES WERE REPAIRED, TESTED TO SPECIFICATIONS AND RETURNED TO THE CUSTOMER. (B)(4).
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.