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

Model Number 97714

Device Problems Pocket Stimulation (1463); Inappropriate/Inadequate Shock/Stimulation (1574); Low impedance (2285); Device Contamination with Chemical or Other Material (2944); Patient Device Interaction Problem (4001)

Patient Problems Undesired Nerve Stimulation (1980); Electric Shock (2554)

Event Type  malfunction  

Manufacturer Narrative

Report source: foreign.(b)(6).If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacturer representative (rep) regarding a patient implanted with an implantable neurostimulator (ins).It was reported that the patient experienced electrical shocking at the ins site.It was noted that the rep was with the patient and/or healthcare professional (hcp) to do further troubleshooting.The zapping at the ins site was positional.The rep programmed low dose and when the patient palpated the ins they were losing stimulation sensation when pressing to the right.The rep was to program the other lead or find another combination on the 0-7 lead.The patient was programmed with electrodes 4 and 5 at the time of the call with the manufacturer's technical services on (b)(6) 2019.All impedance values were normal.Electrode impedance ranged from 586 to 903 ohms, and the group measurement was 854 ohms.The rep would attempt reprogramming and/or speak with the hcp regarding revision.It was noted that the patient was implanted in (b)(6), the leads specifically (b)(6) 2019.The positional zapping had been occurring for the past 10-14 days.A possible fluid short was suspected, and programming low dose and palpating to flush out the fluid short as confirmation.Additional information was received from the rep.It was reported that the cause of the positional zapping was likely a fluid short as per the call to the manufacturer's technical services, but a revision at the pocket site was the only option to explore further.There was no planned revision yet as of (b)(6) 2019.Reprogramming did not resolve the issue.The zapping occurred on both lead channels at the electrode level required for pain relief.There were no further actions/intervention taken yet to resolve the issue.It was noted that this information was confirmed with the physician/account.

Manufacturer Narrative

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

Event Description

Additional information was received from the rep.It was reported that as of (b)(6) 2020, no further actions had been taken.The rep was not aware of any upcoming dates to investigate surgically.

• 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: 9541010
• MDR Text Key: 176574738
• Report Number: 3004209178-2020-00081
• Device Sequence Number: 1
• Product Code: LGW
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2020
• Date Device Manufactured: 03/18/2016
• 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