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

Model Number 97714

Device Problems Failure to Deliver Energy (1211); Inappropriate/Inadequate Shock/Stimulation (1574); Electro-Static Discharge (2149); Insufficient Information (3190)

Patient Problems Fall (1848); Bone Fracture(s) (1870); Muscle Weakness (1967); Pain (1994); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271); Ambulation Difficulties (2544); Electric Shock (2554)

Event Date 07/05/2019

Event Type  Injury  

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 on (b)(6) 2019, the patient was 5 feet away from a phone pole when the phone pole was hit by lightning.They felt a really bad shocking in their back and a continued pulse from the unit.The patient then drove home and the next day they began falling; they fell twice on that saturday and twice on sunday in the grass.They didn't get hurt when they fell but they realized their legs weren't supporting their body anymore, so they tried to lay down.When they went to lay down, they fell and broke their leg in 2 places and they were "there for 17 hours".The patient was on pain medication but when the medication wore off, they felt pain.It was noted that the patient "basically couldn't walk".On (b)(6) 2019, the patient's daughter helped them charge the ins to full however, they weren't feeling stimulation in their back.They commented that apparently after the lightning and shocking, something happened and they lost therapy.An inquiry was made asking if the ins settings could be adjusted because the patient had tried making adjustments but they still were unable to feel stimulation.They were redirected to see the doctor to have the device assessed and possibly get reprogramming.No further complications were reported or anticipated.

Manufacturer Narrative

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

Event Description

Additional information received from the manufacturing representative (rep) and patient indicated that the patient was driving in their car and a lightning bolt hit close by.The patient felt an electrical jolt and their stimulator turned off.The rep stated that impedances were normal.They added that the programs are unchanged, and the patient¿s therapy continues as normal.The patient mentioned that they have to turn amplitude up more since the episode.The issue was resolved at the time of the report.No further complications were 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: 8790868
• MDR Text Key: 151043278
• Report Number: 3004209178-2019-13535
• Device Sequence Number: 1
• Product Code: LGW
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/17/2019

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: 02/28/2016
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/11/2019
• Initial Date FDA Received: 07/15/2019
• Supplement Dates Manufacturer Received: 07/15/2019
• Supplement Dates FDA Received: 07/17/2019
• Date Device Manufactured: 04/08/2015
• 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 Outcome(s): Other
• Patient Age: 57 YR