NUVASIVE DYNAMIC STIMULATION CLIP AND INLINE ACTIVATOR * 2012022

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-05-04 for NUVASIVE DYNAMIC STIMULATION CLIP AND INLINE ACTIVATOR * 2012022 manufactured by Nuvasive Inc.

Event Text Entries

[5796126] Nuvasive dynamic stimulation clip and inline activator was opened and given to the field. It was noted that the seeping on the clip of the device was defective and fell apart before it was touched. It was noted that this was the 3rd product of this kind to malfunction in the same week, however it was determined that the lot numbers were not the same.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 4764959
• MDR Report Key: 4764959
• Date Received: 2015-05-04
• Date of Report: 2015-05-04
• Date of Event: 2014-10-28
• Report Date: 2015-05-04
• Date Reported to FDA: 2015-05-04
• Date Reported to Mfgr: 2015-05-12
• Date Added to Maude: 2015-05-12
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: NUVASIVE DYNAMIC STIMULATION CLIP AND INLINE ACTIVATOR
• Generic Name: ELECTRODE, CORTICAL
• Product Code: GYC
• Date Received: 2015-05-04
• Model Number: *
• Catalog Number: 2012022
• Lot Number: IM0010
• ID Number: *
• Operator: PHYSICIAN
• Device Availability: N
• Device Age: 1 DA
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: NUVASIVE INC
• Manufacturer Address: 7475 LUSK BOULEVARD SAN DIEGO CA 92121 US 92121

Device Sequence Number: 2

• Brand Name: NUVASIVE DYNAMIC STIMULATION CLIP AND INLINE ACTIVATOR
• Generic Name: ELECTRODE, CORTICAL
• Product Code: GYC
• Date Received: 2015-05-04
• Model Number: *
• Catalog Number: 2012022
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Age: 1 DA
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: NUVASIVE INC
• Manufacturer Address: 7475 LUSK BOULEVARD SAN DIEGO CA 92121 US 92121

Device Sequence Number: 3

• Brand Name: NUVASIVE DYNAMIC STIMULATION CLIP AND INLINE ACTIVATOR
• Generic Name: ELECTRODE, CORTICAL
• Product Code: GYC
• Date Received: 2015-05-04
• Model Number: *
• Catalog Number: 2012022
• Lot Number: *
• ID Number: *
• Device Availability: N
• Device Age: 1 DA
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: NUVASIVE INC
• Manufacturer Address: 7475 LUSK BOULEVARD SAN DIEGO CA 92121 US 92121

Patients

Patient Number	Treatment	Outcome	Date
1	0		2015-05-04