MAUDE Adverse Event Report: MEDTRONIC NEUROMODULATION UNKNOWN IMPLANTABLE NEUROSTIMULATOR; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number NEU_INS_STIMULATOR

Device Problems Energy Output To Patient Tissue Incorrect (1209); Inappropriate/Inadequate Shock/Stimulation (1574); Device Or Device Fragments Location Unknown (2590)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099); Malaise (2359); Electric Shock (2554)

Event Date 01/01/2010

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 a neurostimulator for other pain indications ¿ other.It was reported that the patient was unsure how long the device was implanted for; however, she thought that it wasn¿t very long when she started noticing that ¿the thing was shocking her.¿ the shocking was noted to have started occurring sometime in 2010.The patient described it just like sticking your finger in an outlet, being a hard shock.The patient just pulled her head down in her shoulders and turned the device off, but it was still shocking the patient bad.The health care provider let the patient know that he was unsure how the device could still be shocking her when it was turned off.The patient was pretty sick, and the health care provider told her that he was not going to take the ¿battery¿ out as it is not going to hurt anything.The health care provider took the ¿implant¿ out but left the ¿battery¿ and ¿tubing¿ in there all the way up her spine because the battery was good for 7.5 years.The patient mentioned a couple of times that the ¿implant¿ was removed, but the ¿battery¿ remained in the patient.It was reviewed with the patient that the ¿battery¿ and ¿implant¿ are the same thing.[this information was confusing.] additionally, the patient noted that the therapy/implant had never helped her pain and did not work for her.There were no further complications 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.The patient's weight was provided.No further complications were reported.

• Brand Name: UNKNOWN IMPLANTABLE NEUROSTIMULATOR
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer (Section G): MEDTRONIC NEUROMODULATION; 800 53rd ave ne; minneapolis MN 55421 1200
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7381980
• MDR Text Key: 103844813
• Report Number: 3007566237-2018-00920
• Device Sequence Number: 1
• Product Code: LGW
• 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: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NEU_INS_STIMULATOR
• Device Catalogue Number: NEU_INS_STIMULATOR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/12/2018
• 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 Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 61