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

Model Number 97714

Device Problems Migration or Expulsion of Device (1395); Pocket Stimulation (1463); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Muscle Weakness (1967); Pain (1994); Malaise (2359); Electric Shock (2554); Cramp(s) /Muscle Spasm(s) (4521); Insufficient Information (4580)

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 patient who was implanted with an implantable neurostimulator (ins).The reason for call was the patient lost 50 lbs and about a year and a half ago their ins started to move in their pocket.The patient would move the ins around in order to communicate the recharger to the ins.At that point they started to have localized pain in the battery pocket when they pushed on the ins.About 3 months ago their ins pocket started to be sore and if the top of their ins was touched when the touch was released the patient felt a shock at the battery site, the patient said the feeling was different than their typical stimulation.About 1 1/2 months ago they started to have pain radiating down their right leg (on the side of their body where the pocket is).The patient started to feel full body spasms, pain in their legs, sick, colon issues, they felt weak, and their arms and legs felt heavy.The patient turned their stimulation off and the symptoms went away and then about 1 1/2 days after turning their stimulation back on they would again feel these symptoms (the patient did this process a couple of times).They met with pain doctor and they performed x-rays and said they didn't see any lead migrations in either their cervical or lumbar region.The health care provider redirected the patient to a medtronic representative to have further diagnostics performed.The patient was redirected back to their healthcare provider to further address the issue.

• Brand Name: SURESCAN
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• 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: 12055663
• MDR Text Key: 266711419
• Report Number: 3004209178-2021-09878
• 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
• Report Date: 06/23/2021

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: 08/14/2017
• Device Model Number: 97714
• Device Catalogue Number: 97714
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/22/2021
• Initial Date FDA Received: 06/23/2021
• Date Device Manufactured: 09/25/2016
• 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