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U.S. Department of Health and Human Services

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

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MEDTRONIC PUERTO RICO OPERATIONS CO. INTELLIS STIMULATOR, SPINAL-CORD, TOTALLY IMPLANTED FOR PAIN RELIEF Back to Search Results
Model Number 97715
Device Problems Break (1069); Disconnection (1171); High impedance (1291); Appropriate Term/Code Not Available (3191)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/11/2020
Event Type  Malfunction  
Manufacturer Narrative

Concomitant medical products: product id: 97714, serial#: (b)(4), implanted: (b)(6) 2016, explanted: (b)(6) 2020, product type: implantable neurostimulator. Product id: 977a275, serial#: (b)(4), implanted: (b)(6) 2016, product type: lead. Product id: 977a275, serial#: (b)(4), implanted: (b)(6) 2016, product type: lead. Product id: 977a275, serial/lot #: (b)(4), ubd: 27-jun-2020, udi#: (b)(4). Product id: 977a275, serial/lot #: (b)(4), ubd: 23-feb-2020, udi#: (b)(4). If information is provided in the future, a supplemental report will be issued.

 
Event Description

When the implantable neurostimulator was replaced, the physician stated that the 0-7 lead was not seated properly in the old implantable neurostimulator. When he put the same lead into the new battery, after he screwed down, the lead pulled out. They were able to get it secured after inserting again and screwing down with the impedance high on (b)(6) 2015. The patient was reprogrammed post-op with the out of range issues. Impedances were rechecked and 2/4/8/15 were all greater than 40,000 ohms. The manufacturer representative was able to reprogram to get adequate coverage and the patient has their follow-up post-op appointment on (b)(6) 2020.

 
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Brand NameINTELLIS
Type of DeviceSTIMULATOR, 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
david gustafson
7000 central avenue ne rcw215
minneapolis, MN 55432
7635149628
MDR Report Key11008087
MDR Text Key221541970
Report Number3004209178-2020-21861
Device Sequence Number1
Product Code LGW
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP840001
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial
Report Date 12/14/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/15/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number97715
Device Catalogue Number97715
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/11/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured11/06/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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