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

Model Number 7427

Device Problems Intermittent Continuity (1121); Energy Output To Patient Tissue Incorrect (1209); High impedance (1291); Unintended Collision (1429); Pocket Stimulation (1463); Unable to Obtain Readings (1516); Low impedance (2285)

Patient Problems Undesired Nerve Stimulation (1980); Therapeutic Effects, Unexpected (2099); Therapeutic Response, Decreased (2271)

Event Date 01/01/2016

Event Type  malfunction  

Manufacturer Narrative

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 reported from a manufacturing representative regarding a patient.It was reported that the patient felt a surge about 2 months ago.The patient turned their implantable neurostimulator (ins) off, and has left it off until the day of the report.Impedance measurements were taken on the day of the report, and contacts 0-4 and 4-7 were above 4000 ohms.All other impedances were between 500-2000 ohms.The patient does not experience symptoms when the ins is off.It was noted that the patient did fall on (b)(6) 2016.The manufacturing representative programmed the patient around contact 4 and turned their stimulation back on, on the day of the report.It was noted that the patient stated they felt stimulation in the wrong location.It was reviewed that the patient¿s lead may have migrated from the fall.The patient was to follow up with their healthcare provider.The patient was implanted for radicular pain syndrome (radiculopathies).

Event Description

Additional information received from the manufacturing representative indicated that the patient was reprogrammed and receiving sufficient coverage for pain relief.No other action has been taken thus far about a possible battery and lead replacement.

Manufacturer Narrative

(b)(4) no longer applies.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.

Manufacturer Narrative

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

On 2016-12-22 a manufacturer representative called in regarding this event and requested information about the model number of the patient¿s lead.Additional information was received on 2017-01-05 from a manufacturer representative reporting that impedance measurements were taken on (b)(6) 2017 with the following results when run at 3v and 210us: 0/1 had ???, 0/2 had 931, 0/3 had 931, 0/4 had281, 0/5 had 931, 0/6 had 931; 1 /2 had 693, 0/3 had 931, 0/4 had 2815, 0/5 had 931, 0/6 had 931, 0/7 had 931; 2/3 had 693, 2/ 4 had 2815, 2/5 had 931, 2/6 had 931, 2/7 had 931, 3/4 had 2815, 3/5 had 931, 3/6 had 931, 3/7 had 2, 4/6 had 2815, 5/6 had 953, and 6/7 had 693.When measurements were taken at 3v with 90 us there were a lot of ??? values.When measurements were taken with 3v and 300us, the following values were seen: 0/4 had >4000, ¼ had >4000, 0/7 had ????, 3/ 4 had ???, 4/5 had >2000, 4/6 had >2000, and 4/7 had ???.The patient was programmed with 2 programs.Program1 used 0- and 1+ while program 2 used electrodes 5, 6, and 7.The patient claimed to be getting good coverage until the last few months.Stimulation was increasing or decreasing around the pocket area.The manufacturer representative was made aware of these issues on the day of the call (b)(6) 2017.

Manufacturer Narrative

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

• 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: diane wolf ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263987
• MDR Report Key: 6178674
• MDR Text Key: 62540421
• Report Number: 3004209178-2016-26567
• 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,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/06/2017

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 Expiration Date: 09/14/2005
• Device Model Number: 7427
• Device Catalogue Number: 7427
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/14/2016
• Initial Date FDA Received: 12/15/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; 01/06/2017
• Supplement Dates FDA Received: 12/19/2016; 01/06/2017; 01/06/2017; 09/28/2017
• Date Device Manufactured: 03/23/2004
• 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 Age: 75 YR