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

Model Number 97713

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Insufficient Information (3190)

Patient Problems Pain (1994); Ambulation Difficulties (2544); Electric Shock (2554)

Event Date 11/09/2020

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: product id: 97713, serial#: (b)(4), implanted: (b)(6) 2014, product type: implantable neurostimulator if information is provided in the future, a supplemental report will be issued.

Event Description

The patient reports his pain has come back in the last month and maybe could be since the stimulation is turned down so low.Patient states his right implant is depleted but the left implant has some charge left.Later in the call patient states right side might just be low stimulation and its been this way for a couple of weeks.¿patient¿states all his units had shorts and were shocking him.¿patient¿states he has no way to recharge his implant as he shipped back the recharger.¿patient¿states his pain is all coming back and can barely walk.¿patient¿states he doesn't feel anything on the right implant but the left he does feel something.¿patient¿states he turned down really low¿to save the battery inside the implant¿and was at 4.80 and maybe still has stimulation.

• 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: david gustafson ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635149628
• MDR Report Key: 10992842
• MDR Text Key: 220970460
• Report Number: 3004209178-2020-21684
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00643169109490
• UDI-Public: 00643169109490
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2016
• Device Model Number: 97713
• Device Catalogue Number: 97713
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2020
• Date Device Manufactured: 03/10/2015
• 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
• Treatment: "SEE H10...."
• Patient Age: 56 YR