MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO ITREL 3; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR

Model Number 7425

Device Problems Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Electro-Static Discharge (2149); Insufficient Information (3190)

Patient Problem Electric Shock (2554)

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 3587a, lot# n0041103, implanted: (b)(6) 2006 explanted: product type lead.If information is provided in the future, a supplemental report will be issued.

Event Description

The healthcare professional (hcp) reported the patient said the implantable neurostimulator¿(ins) was removed over 10 years ago but lead(s) are still implanted.The caller was asked why the ins was explanted - caller states the patient said lightning struck close to him and turned the ins on (which was previously off).Event date provided: "over 10 years ago".Caller states patient said he could not control the stimulator at this point and went to the hcp the next day to have it removed as the ins was "defective".Caller added that the patient said when the ins was explanted the hcp said something was melted.Caller reports the patient had the ins removed only as he was "too cardiac-compromised to have the whole system removed".Caller states the patient said this was done under local anesthetic and when the wires were cut during the explant surgery "it zapped him".

• Brand Name: ITREL 3
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR
• Manufacturer (Section D): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC MED REL MEDTRONIC PUERTO RICO; 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: 12333693
• MDR Text Key: 266971358
• Report Number: 3004209178-2021-12530
• 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: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/17/2021

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: 08/14/2007
• Device Model Number: 7425
• Device Catalogue Number: 7425
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/09/2021
• Initial Date FDA Received: 08/17/2021
• Date Device Manufactured: 02/15/2006
• 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