MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. SURESCAN; STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)

Model Number	97702
Medical Device Problem Codes	Failure to Deliver Energy (1211); High impedance (1291)
Health Effect - Clinical Code	Therapeutic Effects, Unexpected (2099)
Date of Event	01/27/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Concomitant medical products: product id 3778-60, serial# (b)(4), implanted: (b)(6) 2008, explanted: (b)(6) 2017, product type: lead.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
A patient reported via manufacturer representative that after a recent implantable neurostimulator (ins) replacement surgery on (b)(6) 2017, he was unable to feel any stimulation.Upon interrogating the device, all electrodes were found to be out of order, >10,000 ohms.The lead was replaced with a surgical paddle on (b)(6) 2017.The issue was resolved.The indication for implant was failed back surgery syndrome and spinal pain.
Additional Manufacturer Narrative
(b)(4).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
The lead was returned to the manufacturer for analysis.
Additional Manufacturer Narrative
Concomitant products: product id: 3550-39, product type: accessory.Product id: 3778-60, serial# (b)(4), implanted: (b)(6) 2008, explanted: (b)(6) 2017, product type: lead.Analysis of the lead (b)(4), found that the lead body conductor was broken at the titan anchor site.All conductors were broken 27.4 centimeters from the distal end.(b)(4).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.
Additional Manufacturer Narrative
Other applicable components are: product id: 3550-39, serial# unknown, product type: accessory.Product id: 3778-60, serial# (b)(4), implanted: (b)(6) 2008, explanted: (b)(6) 2017, product type: lead.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: SURESCAN
• Common Device Name: STIMULATOR, SPINAL-CORD, IMPLANTED (PAIN RELIEF)
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• MDR Report Key: 6362702
• Report Number: 3004209178-2017-04696
• Device Sequence Number: 16372038
• Product Code: LGW
• UDI-Device Identifier: 00613994188670
• UDI-Public: 00613994188670
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,consum
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 04/18/2017

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: 03/28/2018
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2017
• Initial Date Received by Manufacturer: 02/23/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided; 04/14/2017; 04/14/2017
• Initial Report FDA Received Date: 02/27/2017
• Supplement Report FDA Received Date: 03/17/2017; 04/14/2017; 04/18/2017; 10/02/2017; 10/02/2017
• 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: 74 YR