MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION SPECIFY SURESCAN; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number 977C165

Device Problems High impedance (1291); Shipping Damage or Problem (1570)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/16/2016

Event Type  malfunction  

Manufacturer Narrative

Product id: 97791, lot# n642967, product type: accessory.Product id: 39565, serial# (b)(4), product type: lead.Product id: 97791, serial# unknown, product type: accessory.Analysis results were not available at the time of this report.A follow up report will be sent when analysis is completed.

Event Description

The lead was returned and the medical representative reported high impedances on 8-15.

Manufacturer Narrative

Analysis of the lead serial# unknown found procedural non-conformance as stimulation lead proximal end connector not completely seated in ins connector port.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: SPECIFY SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6171555
• MDR Text Key: 62346709
• Report Number: 3007566237-2016-04376
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 977C165
• Device Catalogue Number: 977C165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 71 YR