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

Model Number 97714

Device Problems Battery Problem (2885); Charging Problem (2892)

Patient Problems Nerve Damage (1979); Pain (1994); No Known Impact Or Consequence To Patient (2692)

Event Date 12/01/2018

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 an implantable neurostimulator (ins) for non-malignant pain.It was reported that the patient feels they are charging more often than with their old device since (b)(6) 2018 and the battery is not charging for so long.The patient said she is charging every 2-3 weeks compared to every 2 months or so with the old device.The patient said her usage and programming is the same as her old device.The patient said the other device lasted longer and she has stim on all the time because of nerve damage.It was reviewed the difference in battery sizes or difference in settings may be the reason for charging more frequently.It was reviewed the recharging frequency can differ between every battery and every patient.The patient was going to keep a log of charging frequency to determine if it is sporadic or consistent and discuss with their hcp as needed.No further complications were reported.

Manufacturer Narrative

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

Event Description

Additional information was received from the patient on (b)(6) 2019.It was reported that the patient¿s activity had not changed, and they notice the recharging issue when they hurt more than usual in their lower back and left leg where they have nerve damage.The patient noted that they usually don¿t use the controller unless they absolutely have to, they were able to charge the device back up again, and they don¿t let the charge get below 50%.There were no further complications reported or anticipated.

Manufacturer Narrative

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

Manufacturer Narrative

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

Event Description

Additional information from patient indicated she had been having problems with her recharger since (b)(6) 2019.Patient noted it took her more than 2 hours to charge her ins.Patient mentioned she had been charging since 8 this morning and still had not gotten past the ¿3rd part¿.Patient mentioned she spoke with rep about this and would call back if the issue was not resolved.It was noted coupling bars went up and down, it never got it fully 100% charge.Prior the call, patient confirmed her coupling bars seemed to fluctuate up and down and her ins was never filled to 100%.A replacement recharger antenna would be sent, recharger antenna was damaged.There were no further complications 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: 8281998
• MDR Text Key: 134251394
• Report Number: 3004209178-2019-01844
• 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: consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2019
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/04/2019
• Date Device Manufactured: 03/07/2018
• 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: 59 YR
• Patient Weight: 86