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

Model Number 97714

Device Problems Failure to Deliver Energy (1211); High impedance (1291); Unexpected Therapeutic Results (1631); Application Program Problem (2880); Human-Device Interface Problem (2949)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 08/02/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from the patient via a manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins) for failed back surgery syndrome and spinal pain.It was reported that the patient stated, despite turning up their stimulation, they were unable to feel any stimulation at all.It was unknown if there were any factors that may have contributed to the issue.The rep interrogated the battery and turned the stimulation all the way up, but the patient was unable to feel any stimulation.The rep ran an impedance check and all contacts on 8 through 15 were greater than 10,000 ohms except for contact 10 and 14.Lead 0 through 7 impedances were all within normal limits (wnl), but that lead was not programmed due to their pain mostly being on their right side.The rep programmed around the high impedance contacts using contacts 10 and 14.It was unknown if the issue was resolved at the time of the report and the rep indicated that they would follow-up for more information.No surgical intervention has occurred at this time and it was unknown if surgical intervention would be planned, but the rep indicated that they would follow-up for more information.It was reported that the event occurred on (b)(6) 2018.No further complications were reported/anticipated.

Manufacturer Narrative

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

Event Description

Additional information was received from the manufacturer representative (rep) reporting that reprogramming around the high impedances using contacts 10 and 14 resolve the patient's issue of being unable to feel stimulation and having pain.The rep indicated that surgical intervention was not planned or scheduled at this time.No further complications were reported/anticipated.

Manufacturer Narrative

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

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR 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: 7757254
• MDR Text Key: 116898293
• Report Number: 3004209178-2018-17556
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109483
• UDI-Public: 00643169109483
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/03/2018
• Initial Date FDA Received: 08/07/2018
• Supplement Dates Manufacturer Received: 08/08/2018; 08/08/2018
• Supplement Dates FDA Received: 08/17/2018; 10/04/2018
• Date Device Manufactured: 12/17/2015
• 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: 30 YR