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

Model Number 37702

Device Problem Therapy Delivered to Incorrect Body Area (1508)

Patient Problems Incontinence (1928); Undesired Nerve Stimulation (1980); Pain (1994)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: product id: 37701, serial#: (b)(4), implanted: (b)(6) 2014, explanted: (b)(6) 2015, product type: implantable neurostimulator.Product id: 3093-28, lot#: v162344, implanted: (b)(6) 2008, product type: lead.Product id: 3093-28, lot#: v162344, implanted: (b)(6) 2008, product type: lead.Other relevant device(s) are: product id: 3093-28, serial/lot #: v162344, ubd: 07-oct-2012, udi#: (b)(4); product id: 3093-28, serial/lot #: v162344, ubd: 07-oct-2012, udi#: (b)(4).Device used for off label indication.The indication the device was used for was urinary dysfunction/sacral nerve stim and gastrointestinal/ pelvic floor.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a patient regarding their implantable neurostimulator (ins).Information was reported that the patient stated the device that was placed in 2014 (nkd703410h) did not help with fecal incontinence.The patient stated is also gave her pain in pelvic region.The patient went to her healthcare provider (hcp) multiple times for reprogramming with hcp staff and manufacturer representatives (reps).The patient stated the rep also called pats for assistance.The patient stated she would not feel stimulation in the correct area.The patient stated she had surgery three times to reposition the leads in 2014, 2015, and 2016.The patient was implanted with another ins, but stated she had it removed.The patient also noted having reconstructive surgery on her pudendal nerve.The patient stated the leads are placed correctly, but the sensation is not going to where it was supposed to be going.The patient stated the hcp retired and she is probably going to see a doctor.Additional information was reported that since the doctor performed procedures and used the leads in an off label manner the manufacturer representative (rep) were not able to provide technical assistance to either the patient or doctor during these cases.The reps were also not able to provide assistance with programming.No further information was reported.

• Brand Name: PRIMEADVANCED
• 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: 9982591
• MDR Text Key: 188403676
• Report Number: 3004209178-2020-07434
• Device Sequence Number: 1
• Product Code: LGW
• UDI-Device Identifier: 00613994842312
• UDI-Public: 00613994842312
• 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: company representative,consum
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/21/2020

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: 08/28/2016
• Device Model Number: 37702
• Device Catalogue Number: 37702
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/13/2020
• Initial Date FDA Received: 04/21/2020
• Date Device Manufactured: 03/13/2015
• 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: 47 YR