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

Model Number 97712

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Operates Differently Than Expected (2913); Improper Device Output (2953)

Patient Problems Therapeutic Effects, Unexpected (2099); Discomfort (2330); Electric Shock (2554)

Event Date 05/15/2018

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 consumer regarding a patient who was implanted with an implantable neurostimulator (ins) for non-malignant pain.It was reported that the patient was having problems with turning off the device and was experiencing buzzing or shocks even when they turned the device off and unplugged it from the power source.It was noted that the patient wasn't experiencing overstimulation sensation.The caller later stated that the patient was experiencing uncomfortable stimulation.They spoke to a representative earlier in the day regarding charging but at that time the uncomfortable stimulation wasn't present.The patient connected to the ins and it showed that the ins was on.They turned the ins off and that resolved the issue.No further complications reported.

Manufacturer Narrative

Device code (b)(4) and patient code (b)(6) no longer apply.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received from the consumer.It was reported that when asked if the patient experienced shocking, uncomfortable stimulation, or both, they answered that the patient experienced uncomfortable stimulation.As soon as a technician was contacted they told them what to do and all was fine.The consumer noted that they were charging the battery in a rehab facility.Upon shutting the ins off the patient received lots of "buzzing".No further complications reported.

• 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: 7526300
• MDR Text Key: 108728717
• Report Number: 3004209178-2018-11284
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109506
• UDI-Public: 00643169109506
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/14/2017
• Device Model Number: 97712
• Device Catalogue Number: 97712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2018
• Date Device Manufactured: 12/22/2016
• 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: 84 YR
• Patient Weight: 91