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

Model Number 97714

Device Problems Failure to Deliver Energy (1211); Charging Problem (2892); Device Operates Differently Than Expected (2913); Electromagnetic Compatibility Problem (2927)

Patient Problems Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 12/22/2016

Event Type  Injury  

Manufacturer Narrative

Other applicable components are: product id: 3982a, implanted: (b)(6) 1989.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 Description

Information was received from a health care provider (hcp) via a company representative (rep) regarding a patient that was implanted with an implantable neurostimulator (ins).It was reported that the patient experienced a loss of response on (b)(6) 2017.The patient commented that the device needs to be recharged more often and recharging was faster.An external factor that contributed to the event was angiography made closely to the loss of response.The troubleshooting/actions performed were: tried to program and even 10.5v 1000micros 40 hz did not give any signs.X ray pictures were also taken.The action taken to resolve the event was programming.The issue was not resolved at the time of this event.The lead and ins status was reported as implanted-out of service.It was unknown if surgical intervention occurred.The patient was alive with no injury.No further complications were reported or anticipated.

Manufacturer Narrative

The main component of the system and other applicable component is: product id: 3982a, implanted: (b)(6) 1989, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information from the healthcare professional via the manufacturer representative reported the lead was changed and the problem no longer exists.The ins remains in service.

Manufacturer Narrative

The main component of the system and other applicable components is: product id: 977c190, serial (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2017, product type: lead.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information from the healthcare professional via the manufacturer representative reported the lead would not be returned as it was discarded by the customer.

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 MN 00777 1200
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos,pr MN 00777 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6630330
• MDR Text Key: 77633350
• Report Number: 3007566237-2017-02297
• Device Sequence Number: 1
• Product Code: GZB
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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,Followup
• Report Date: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2015
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2017
• Date Device Manufactured: 11/06/2014
• 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