MAUDE Adverse Event Report: MDT SOFAMOR DANEK PUERTO RICO MFG ITREL 3; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 7425

Device Problems Labelling, Instructions for Use or Training Problem (1318); Device Or Device Fragments Location Unknown (2590); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/27/1999

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id 3587a, lot# l66825, implanted: (b)(6) 1999, product type: lead.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received about a patient with an implantable neurostimulator (ins) for failed back surgery syndrome and spinal pain, chronic low back pain and spinal pain.It was reported that the patient was calling for guidelines for an unrelated brain mri.The patient reported that their doctor told them that they couldn¿t have any mris and another doctor said the patient could have one done on their head.It was reported that the patient received a fax from their doctor saying that the ¿old¿ stimulator (ins) was removed along with the extension, and they had pulled as much of the lead out as they could and then cut the lead off with a big scissors.It was reviewed that based on that note it sounded like the patient may have had a lead fragment left in their body as they were unable to remove the whole lead.The patient was advised that if the lead fragment wasn¿t in the head coil, then they may still be able to have a head mri.It was reported that this device had never worked right since implant ((b)(6) 1999).

Manufacturer Narrative

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

• Brand Name: ITREL 3
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• Manufacturer (Section D): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer (Section G): MDT SOFAMOR DANEK PUERTO RICO MFG; barrio marianna rd 909, km0.4; humacao PR 00792
• Manufacturer Contact: lisa clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 6389792
• MDR Text Key: 69437222
• Report Number: 1030489-2017-00477
• 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: 03/08/2017

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 Model Number: 7425
• Device Catalogue Number: 7425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/03/2017
• Initial Date FDA Received: 03/08/2017
• Supplement Dates Manufacturer Received: 03/03/2017
• Supplement Dates FDA Received: 10/02/2017
• 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: 58 YR