D
Patient 1
IT WAS REPORTED THAT THE DEVICE WAS NOT PRODUCING ENOUGH. THERE WAS NO PATIENT CONTACT, NO PATIENT PREPPED FOR SURGERY, NO PATIENT INJURY, AND NO DELAY IN SURGERY.
MAUDE MDR 4905137
- MDR report key
- 4905137
- Report number
- 1222895-2015-00031
- Event key
- 0
- Event type
- 3
- Date received
- 2015-07-08
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MRS. ROWENA BUNUAN
- Address
- 311 ENTERPRISE DRIVE PLAINSBORO NJ 08536 US
- Phone
- 609-609-6099
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | OJEMAN CORTICAL STIMULATOR | NA | INTEGRA BURLINGTON, MA, INC. | GYC | OCS2 | Y | R |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-07-08 | 0 |
Event Narratives#
N
Patient 1
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.
N
Patient 1
INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON (B)(4) 2015 . THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE. REVIEW OF DEVICE HISTORY RECORDS. REVIEW OF COMPLAINTS HISTORY. RESULTS: THE COMPLAINT INCIDENT WAS DUPLICATED. THE OCS2 DHR WAS REQUESTED FROM THE MANUFACTURING FACILITY INTEGRA BILLERICA APPENDIX 1. THE DHR WAS REVIEWED FOR OCS2 OJEMAN CORTICAL STIMULATOR SERIAL NUMBER 1131. DATE OF MANUFACTURE: 2008 ?DEC. NO NON-CONFORMANCE REPORTS WERE RAISED DURING THE MANUFACTURING PROCESS FOR THIS MONITOR. THE DHR REVIEW VERIFIED ALL THE FUNCTIONALITY TESTS WERE CARRIED OUT ACCORDINGLY AND ALL RESULTS OF THE TESTS WERE RECORDED AS WITHIN SPECIFICATION PRIOR TO THE OCS2 BEEN RELEASED. RATE OF OCCURRENCE: DURING THE TIME PERIOD ?JUN 2014 TO NOV 2015, THE QUANTITY OF COMPLAINTS (B)(4) OVER THE REVIEW PERIOD WITH THE KEY WORD IDENTIFIED IN THE COMPLAINT REVIEW CAN THEREFORE BE CALCULATED AS (B)(4). CONCLUSION: THE ROOT CAUSE OF THE COMPLAINT INCIDENT WAS VERIFIED AS LOOSE BATTERY CLIPS CAUSING AN INTERMITTENT POWER SUPPLY TO THE OCS2 MONITOR.