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

Model Number 97702

Device Problems Device Operates Differently Than Expected (2913); Electromagnetic Compatibility Problem (2927)

Patient Problem Dizziness (2194)

Event Date 06/01/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a consumer regarding a patient who was implanted with a neurostimulator for spinal pain.It was reported that on (b)(6) 2017, the patient felt like she was passing out, and supposedly when the patient¿s pacemaker was checked, they noted interference.When the spinal cord stimulation was turned off, the patient was feeling fine.They also noted the experience once in (b)(6) of 2017.It was unknown if there was testing for interference during implantation.The pacemaker is on the left chest, and the implantable neurostimulator is in the left buttocks and the lead is at t8-t10, with electrodes 4+, 5-, 6-.There were no further complications reported.

Manufacturer Narrative

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

Event Description

Additional information was received from a manufacturer representative (rep) on november 10, 207.It was reported that no changes were made to the programming and the patient was referred to her cardiologist to possible adjust the sensitivity of her pacemaker.It was unknown if the interference was mutual or not, it is unknown how the devices were affected by the interference, the cause of the interference was unknown and it was unknown if the issues resolved.There were no further complications reported or anticipated.

• 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: 7016121
• MDR Text Key: 92716377
• Report Number: 3004209178-2017-23492
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109513
• UDI-Public: 00643169109513
• 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
• Report Date: 11/21/2017

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: 07/14/2018
• Device Model Number: 97702
• Device Catalogue Number: 97702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/26/2017
• Initial Date FDA Received: 11/09/2017
• Supplement Dates Manufacturer Received: 11/10/2017
• Supplement Dates FDA Received: 11/21/2017
• Date Device Manufactured: 01/16/2017
• 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: 85 YR