MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number	NEU_INS_STIMULATOR
Medical Device Problem Codes	Break (1069); Device Operates Differently Than Expected (2913); Impedance Problem (2950)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/28/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
Information was received from a manufacturer representative (rep) regarding a patient.It was reported that there was a revision surgery to replace an extension in (b)(6).
Event or Problem Description
Additional information was received from the manufacturer representative stating that the previously implanted extension was connected to the new ins, impedance check showed all were out of range.Replaced the bifurcated extension with new 37082 but when plugging the left 0-3 tail of the existing 3998 paddle, some of the silicone outer covering of the lead sheared.When connected into the bifurcated extension and impedance check done with 355531 mltc, impedances on all electrodes except #3 were within normal limits.Electrode #3 has been out of range for years.
Event or Problem Description
Additional information received from the manufacturer representative reported that the cause of the shearing was unknown and the out of range impedances had not been resolved.It was noted that electrode 3 had been out of range for years and remained so.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
All previously reported codes are still applicable for this event.The main component of the system and other applicable components are: product id: 3708240, serial (b)(4), product type: extension.If information is provided in the future, a supplemental report will be issued.

• Common Device Name: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis,mn PR 55421 1200
• MDR Report Key: 6358959
• Report Number: 6000153-2017-00011
• Device Sequence Number: 984980
• Product Code: LGW
• UDI-Device Identifier: 00885074404516
• UDI-Public: 00885074404516
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2009
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 12/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/15/2013
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2017
• Supplement Date Received by Manufacturer: Not provided; 02/25/2017; 12/05/2017; 12/06/2017
• Initial Report FDA Received Date: 02/24/2017
• Supplement Report FDA Received Date: 02/28/2017; 10/02/2017; 12/05/2017; 12/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 57 YR