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

Model Number 97714

Device Problems High impedance (1291); Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913)

Patient Problem Electric Shock (2554)

Event Date 01/31/2017

Event Type  malfunction  

Manufacturer Narrative

Other applicable components are: product id: 3708120, serial#: (b)(4), product type: extension.Product id: 3708120, serial#: (b)(4), product type: extension.

Event Description

Information was received from a patient with an implantable neurostimulator (ins) for the treatment of non-malignant pain.It was reported that the wires were failing on the table during the ins replacement surgery on (b)(6) 2017.The patient reported that out of the 16 ¿wires,¿ only 8 were working, and once they woke up from the surgery, only 7 were working.It was noted that it was an extension in the back that had failed, but it was not specified which extension failed.When the patient was in recover after the procedure, the device was "going crazy" and sporadically shocking the patient.The programming was turned down.No further complications are anticipated.Addition information was received from a manufacturer representative.It was reported that there was high impedance during the surgery when tested at 0.7v.The impedances read normal when tested at a higher voltage of 3v.After the surgery, there was still high impedance when tested at 0.7v.The cause of the high impedance was unknown at the time of the event.It was also reported that the shocking that occurred after the procedure dissipated when the stimulation was turned down.It was noted that the electrodes could not have been tested prior to the procedure because the surgery was only performed to replace the battery and use the wires that were already implanted.No further complications are 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, 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: 6428382
• MDR Text Key: 70769206
• Report Number: 3004209178-2017-06234
• Device Sequence Number: 1
• Product Code: GZB
• 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
• Report Date: 03/23/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2017
• 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: 03/15/2017
• Initial Date FDA Received: 03/23/2017
• Supplement Dates Manufacturer Received: 03/15/2017
• Supplement Dates FDA Received: 10/02/2017
• Date Device Manufactured: 04/08/2016
• 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: 44 YR