MAUDE Adverse Event Report: MEDTRONIC MED REL MEDTRONIC PUERTO RICO SYNERGY; STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF

Model Number 7427

Device Problems Failure to Deliver Energy (1211); High impedance (1291); Unable to Obtain Readings (1516); Battery Problem (2885)

Patient Problems Pain (1994); Therapeutic Effects, Unexpected (2099)

Event Date 07/09/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Information was received by a manufacture representative (rep) regarding a patient with an implantable neurostimulator (ins) for failed back surgery syndrome.It was reported that the rep was called to interrogate the patient¿s ins.The rep stated about a month ago, the patient started to have pain in their leg.It was reported that the pain came and went so the patient checked with their patient programmer and it wouldn¿t do anything.The rep stated the ins voltage was 2.08v and the ins status was eol (end of life).The caller was able to turn the ins on but the patient didn¿t feel anything.The rep had already run impedances and provided the following results: 5-7 ??? 5-6 1442 4-7 over 4k 4-6 ??? 4-5 1442 3-7 over 4k 3-6 over 4k 3-5 over 4k 3-4 1442 2-7 over 4k 2-6 over 4k 2-5 over 4k 2-4 1442 2-3 714 1-7 over 4k 1-6 over 4k 1-5 over 4k 1-4 over 4k 1-3 over 4k 1-2 over 4k technical services reviewed the potential that the ins likely dropped below the voltage trip point to turn off and/or por and then the voltage rebounded so they were able to turn ins on, but it would likely turn off again.Technical services reviewed the ins will need to be replaced but suggested running impedances now that the ins had been on for a few minutes and running at 3v to get a more accurate measurement and hopefully clear the ??? readings.It was reported the event began about a month ago in 2018.No further complications were reported/anticipated.

Manufacturer Narrative

Product id (b)(4) lot# serial# (b)(4) implanted: explanted: product type programmer, patient if information is provided in the future, a supplemental report will be issued.

Event Description

Additional information reported that the stimulation was lost at 2.08v.It appeared the programmer would not work because the device was at eol.The cause of the issues was unknown.The device would be replaced and the high impedances would be evaluated at that time.The patient was referred to a neurosurgeon.No further complications were reported/anticipated.

Manufacturer Narrative

Continuation of d11: product id 7435 lot# serial# (b)(4) implanted: 2000-(b)(6) explanted: product type programmer, patient pr oduct id 3887-33 lot# l74038 serial# implanted: 2000-(b)(6) explanted: product type lead product id 3587a lot# l70878 serial# implanted: 2000-(b)(6)explanted: product type lead product id 97702 lot# serial# (b)(4) implanted: 2018-(b)(6) explanted: product type implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information was received from a manufacturer representative (rep) reporting that the explanted ins would not be returned for analysis as the facility disposed the ins.No further complications were reported/anticipated.

Manufacturer Narrative

Product id 7435, serial# (b)(4), implanted: (b)(6) 2000.Product type programmer, patient product id 3887-33, lot# l74038, implanted: (b)(6) 2000.Product type lead, product id 3587a, lot# l70878, implanted: (b)(6) 2000.Product type lead, product id 97702, serial# (b)(4), implanted: (b)(6) 2018.Product type implantable neurostimulator.If information is provided in the future, a supplemental report will be issued.

Event Description

After the device was replaced, the impedances continued to be high.The cause remained unknown.Stimulation was able to be achieved on limited contacts.The patient was going to see how they do with the stimulation and will evaluate if they would like to replace the leads.No further complications were reported.

• Brand Name: SYNERGY
• Type of Device: STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF
• 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: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 7777546
• MDR Text Key: 117271970
• Report Number: 3004209178-2018-18077
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2010
• Device Model Number: 7427
• Device Catalogue Number: 7427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/11/2018
• Date Device Manufactured: 05/01/2009
• 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: 72 YR