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

Model Number 97712

Device Problem High impedance (1291)

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

Event Date 12/21/2016

Event Type  malfunction  

Manufacturer Narrative

Information references the main component of the system.Analysis results were not available at the time of this report.A follow-up report will be sent when analysis is completed.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 Description

A manufacturing representative (rep) reported they were doing a brand new implant with a lead.There were no extensions and when they hooked up the lead implantable neurostimulator (ins) they had high impedance.They removed the lead an wiped it off and reconnected and tested at a higher voltage, but the obtained similar results.Then they tested in the mltc and both sides were fine.They opened a new ins and got similar high impedance.With the 1st ins, 4,5 were fine, but everything else on 0-7 were high.They noted 8-15 were normal and now 3 was fine, but everything else 0-7 was out.During troubleshooting the rep swapped lead tails into opposite ports on the 2nd ins and ran impedance at 3v.They indicated the lead that had been having issues was okay in the 8-15 port, and only contact 3 was over 40,000ohms.The rep then swapped lead tails into opposite ports on the 1st ins and again, the issue seemed to follow the lead as 0-7 port was fine and contact 15 on 8-15 was out.They tried the mltc again and everything tested fine.There was not visible damage to the leads.The rep indicated they would be implanting the 2nd ins.The issue occurred intra-operation and there were no symptoms reported.Follow up information from the rep stated the lead was positioned with the tip in the right gutter and the proximal end of the lead midline and they thought it anatomical.They stated that the system was working fine and the patient was getting good coverage.All impedances were 1500-1600 as of the report on (b)(6) 2016.The ins was indicated for spinal pain.

Manufacturer Narrative

Analysis of the ins ((b)(4)) found no evidence of anomalies.

Manufacturer Narrative

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

• Brand Name: SURESCAN
• Type of Device: 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
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6215848
• MDR Text Key: 63691011
• Report Number: 3004209178-2016-27472
• Device Sequence Number: 1
• Product Code: GZB
• UDI-Device Identifier: 00643169109506
• UDI-Public: 00643169109506
• 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: 01/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2017
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/21/2016
• Initial Date FDA Received: 12/30/2016
• Supplement Dates Manufacturer Received: Not provided; 12/29/2016
• Supplement Dates FDA Received: 01/23/2017; 09/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2016
• 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: 73 YR