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

Model Number 97714

Device Problems Migration or Expulsion of Device (1395); Unable to Obtain Readings (1516); Connection Problem (2900); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); No Known Impact Or Consequence To Patient (2692)

Event Date 07/11/2017

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id: 37082-20, serial# (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2017, product type: extension.Product id: neu_unknown_lead, serial# unknown, implanted: (b)(6) 2014, product type: lead.(b)(6).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

Information was received from a healthcare professional (hcp) reported through a manufacturer representative that the lead had moved and wasn¿t helping where it was placed.The leads hadn¿t been working for some time and the patient experienced more pain.Troubleshooting and/or action was taken prior to lead replacement surgery.During lead placement surgery the operating physician was ¿unable to unscrew the extension from the header block¿ of the implantable neurostimulator (ins).It was stated that ¿when screwing the torque wrench, it kept turning the extension around and the doctor couldn¿t do up properly.¿ a different torque wrench was tried, but did not resolve the issue.The setscrew issue was with the ins.Impedance testing was performed and found ¿invalid¿ values.There were no known external factors that contributed to the event.Attempts to unscrew the extension from the ins were unsuccessful; the ins and extension were replaced as a result of the event and the issue was resolved.The patient was alive with no injury.There were no further complications reported or anticipated.

Manufacturer Narrative

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

Event Description

The company representative clarified that the lead that migrated was also replaced.The cause of the lead migration was not known.It was noted the patient has four leads.

Manufacturer Narrative

Analysis of the implantable neurostimulator (ins) found no anomalies.Analysis of the extension found the connector on the extension¿s proximal end was crushed.It was noted the ins¿s #8 setscrew was not tight to the extension and as returned, the #1 connector was the extension was under the setscrew connector block and had been crushed.It was further noted that after removal of the extension from the ins, it was observed that the #0 and #1 extension connectors had been crushed by overtightening of the ins setscrew.Additionally, it was observed that the extension¿s #7 setscrew connector block had been twisted in the molded rubber.Functional testing of the extension found the #1 and #5 circuits were intermittent due to damage at the proximal end.If information is provided in the future, a supplemental report will be issued.

Event Description

No further complications were reported or anticipated.

• 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 woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6768302
• MDR Text Key: 81901780
• Report Number: 3004209178-2017-16275
• Device Sequence Number: 1
• Product Code: LGW
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P840001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 69 YR