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

Model Number 97702

Device Problems Electromagnetic Interference (1194); Loss of Data (2903); Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 08/06/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Information was received from a patient who was implanted with a neurostimulator for non-malignant pain.It was reported that the patient went to have an mri the day prior to the report.At the time of the report, he could not pull up group c anymore on his implantable neurostimulator (ins) which controlled pain on one side of his spine.A manufacturer representative (rep) was contacted to follow-up with the patient.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

Additional information was received from a manufacturer representative (rep).It was reported that group c was reprogrammed and the patient's pain has been resolved.No further complications were reported.

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: 7763027
• MDR Text Key: 117019837
• Report Number: 3004209178-2018-17700
• 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,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: 04/14/2019
• 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: 08/07/2018
• Initial Date FDA Received: 08/08/2018
• Supplement Dates Manufacturer Received: 08/28/2018; 08/08/2018
• Supplement Dates FDA Received: 09/12/2018; 10/04/2018
• Date Device Manufactured: 10/26/2017
• 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: 70 YR